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George - Prof international business - South Bend
$20/h
Unfortunately, this teacher is unavailable
Pending approval
Response Time 24h
Lessons offered by George
  • Individual
The lessons will be held
Taught subjects
  • International Business
Levels
  • Elementary School
  • Middle School
  • Sophomore
  • Junior
  • Senior
  • Advanced Technical Certificate
  • College / University
  • Adult Education
  • MBA

32 Year International Regulatory and Quality Consultant offering to teach international business, chemistry, and manufacturing lessons to students within the greater South Bend (Michiana) IN USA area.

Methodology

Not only was I a teacher's aid and tutor while in college, I am now a substitute teacher at a local IN high school. While teaching and tutoring, I utilize both types of methodologies (i.e. teacher-centered approach and student-centered approach). For the teacher-centered approach, I use a traditional direct expert instructional approach; whereas, for the student-centered approach, I am a facilitator and delegator. In both cases, I also talk but also listen.

Background

I am a pharmaceutical, biologic, and medical device regulatory compliance and quality assurance consultant with over 21 years as an FDA analyst and investigator and over 12 years as an industry consultant and contractor. My duties include teaching quality and regulatory concepts to governmental and industry personnel. I have 2 BS degrees (Chemistry and Metallurgical Engineering), 2 master degrees (an MBA in International Business and an MS in Regulatory Affairs), and am currently obtaining my Ph.D. in International Business.

Rates

Rate for online lessons : $20/h
Lessons offered by George
Individual
The lessons will be held
at your home
Taught subjects
  • International Business
Levels
  • Elementary School
  • Middle School
  • Sophomore
  • Junior
  • Senior
  • Advanced Technical Certificate
  • College / University
  • Adult Education
  • MBA

George's resume

BIOGRAPHY


A. Education

I am currently transitioning from a food, cosmetic, drug, biologic, clinical, medical device, and combination product non-technical quality assurance and regulatory compliance expert to an experienced educator teaching secondary children and/or adults in various areas of science, engineering, business, technology, and/or regulatory affairs, including medical device regulatory compliance, chemistry, metallurgical engineering, sociology, earth science, international travel, governmental operations, international business, management, and general business.

B. Regulatory Compliance

I am a 32-year food, cosmetic, drug, biologic, clinical, medical device, and combination product non-technical quality assurance and regulatory compliance veteran with over 21 years of FDA/ governmental experience as an analyst and level II certified international medical device investigator and over 10 years of industrial experience as a medical device, biologic, pharmaceutical, food, and tobacco products industry quality assurance consultant, regulatory compliance specialist, and ASQ certified quality biomedical auditor. As such, I am familiar with all types of FDA and internationally regulated products and operations.

My educational background includes 2 BS degrees in Chemistry and Metallurgical Engineering from the University of Notre Dame, an MBA in International Business from Indiana University, and a MS in Regulatory Affairs for Drugs, Biologics, and Medical Devices with a concentration in Regulatory Compliance from Northeastern University. As such, not only do I have vast internal working knowledge of FDA operations, but he also understands the need to balance industry business goals against external regulations, the linkages between the various quality system and clinical subsystems, and the struggles with quality, cultural, and business barriers to achieve sound quality systems.

Not only have I inspected, investigated, and audited all types of US and foreign food, cosmetic, drug, biologic, medical device, combination product, and clinical facilities, but also performed various quality assurance and regulatory compliance operations for various FDA and international governmental bodies’ regulated industries, such as monitoring and maintaining product and quality system failure investigations, non-conformances, complaints/ MDRs, and CAPAs, reconciling and analyzing numerous quality system data, writing and revising numerous top and mid-level written procedures, training various governmental and industry personnel in the areas of medical device quality, quality system, design control, and documentation and change control, and informing management and staff of current FDA and international enforcement policies.

My expertise is primarily in medical device and combination product quality assurance and regulatory compliance, and has vast knowledge utilizing U.S., European Union, Canadian, Australian, Brazilian, Japanese, Chinese, and other international medical device and combination product quality system, regulatory, legal, and clinical laws, regulations, standards, and guidelines. However, I am also familiar with and knows the similarities and differences between US food, human and animal pharmaceutical, cosmetic, biologic, tissue, clinical, and tobacco product laws, regulations, guidelines, and operations as well.

I am a self-starter with good written and oral communications skills and has a strong history and a proven and successful track record of accomplishment through leading and/or working with teams. I strive for continuous improvement, consistency in quality assurance and regulatory compliance with reduced waste while auditing, consulting, and contracting medical device, biologic, and pharmaceutical facilities. I have participated in multiple projects to problem solve and has participated in and/or set up quality audit teams and wrote team reports while in the governmental and industrial capacities. In all projects, I have demonstrated hands on expertise in various regulatory compliance and quality assurance activities. As such, these expert skills and knowledge have resulted in increased quality, regulatory, legal, business, and operating integrity for not only the management and staff I have assisted, but also for the greater protection of the U.S. and international consumers as well.

In addition, I am not the typical regulatory compliance and quality assurance expert. Not only do I understand the inner workings of the FDA and regulated industries and staff, but also understands international business and management operations too. My Myers-Briggs profile is also non-typical as well (i.e. an ‘off-the-chart’ ENFP profile, which is in the direct opposition to many quality and regulatory personnel). Unlike many people, I excel in public speaking and mentoring/ coaching others to succeed. Also, due to my strong “highly moral and ethical” beliefs, I am not afraid to challenge and educate unethical and immoral personnel so that they may understand the legal and regulatory consequences of their questionable and biased actions. These additional strengths have given me the necessary skills to multi-task, work as a team player, and be a leader, coach, and mentor while understanding the mechanisms of quality systems and the subsystem linkages balanced with the internal and external business constraints of clients. Therefore, for over 32 years, I have successfully assisted numerous US and foreign companies to achieve quality and regulatory compliance, especially in the medical device and combination product arenas.

OBJECTIVE
To transition more than 32 years of professional experience from a government and an industry environment, into an education position utilizing my analytical, business, scientific, communication and creative skills in the non-technical quality assurance and regulatory compliance areas of domestic and international drug, biologic, and medical device realms.

BACKGROUND

A. Education

I am currently transitioning from a regulatory compliance and quality assurance expert into an experienced educator. Currently, I am obtaining expertise through academics (which will include educational fiend work and student teaching) and work at various IN schools (which will include substitute teaching business and technology courses to high school students).

B. Regulatory Compliance

I am an ASQ certified (QBA) medical device regulatory compliance and non-technical quality assurance expert, specializing in medical device quality systems. My career has been concentrating on US/ EU/ Canadian/ Australian/ Brazilian/ Japanese/ Chinese medical device auditing, investigating, compliance, and regulatory (except for preparing regulatory submissions). Thus, I am not a quality engineer or a regulatory affairs specialist; nor have i set up or how to perform process validations, design projects, nor have written any regulatory submissions (i.e. 510(k)'s, PMA's, technical files, or design dossiers). However, I have audited and reviewed thousands of written procedures, quality records, quality system records, regulatory submissions, process validations, and design studies to see if they conform to external laws, directives, regulations, standards, and guidance, have seen all types of quality system and clinical operations, conducted gap analyses/ data reconciliations, and have given training and guidance to both governmental and industry personnel in these and other pharmaceutical, biologic, and medical device areas for over 32 years. I have also performed various hands-on non-technical quality assurance and regulatory compliance operations, such as preparing/ revising written procedures, preparing 21 CFR 803 baseline reports, conducting out of specification investigations, performing data reconciliations, and monitoring and maintaining complaints, non-conformances and CAPA's. I am willing to take assignments anywhere worldwide and travel 100% (including internationally).








SUMMARY

A. Regulatory Compliance

A Self-starter with good written and oral communications skills and over 32 years of professional experience as a level II certified international medical device investigator in the US government or as a contract quality assurance consultant and regulatory compliance specialist in the medical device industry. I have a strong history and a proven track record of leading or working with the team in quality auditing of domestic and international class I/III medical device products, facilities and operations. I strive for continuous improvement, and Consistent Quality Assurance with reduced waste while auditing, consulting, and contracting medical device facilities. This includes auditing, reviewing, and critiquing all Validation/ Verification, protocol documentation, set up testing, build fixtures Define and Setup Quality Assurance programs and train personal (in-house, and/or contractors, local and offshore) while insuring a quality FDA QSR and/or ISO 9000-9003 certified build. I have participated in multiple projects to problem solve while working in the government arena and as a medical device consultant. I have participated in and/or set up quality audit teams and wrote team reports while in the government or as a consultant. Audited, reviewed, and critiqued FMEA's, data and ongoing design considerations. In all audit and consulting projects, I have demonstrated hands on expertise. These skills have resulted in increased quality and operating integrity.

PROFILE

A. Regulatory Compliance

Medical Device quality assurance and regulatory compliance professional with more than 32 years of progressive experience. A diverse background in quality consulting, auditing, manufacturing, and pharmaceutical, biologic, and medical device operations, with vast experience in the medical device industry, internal FDA operations, and the international business arena.

HIGHLIGHTS OF QUALIFICATIONS
• Medical Device Compliance • Results Oriented • Problem Resolution
• Failure Modes & Effects Analysis • Strong Negotiation Skills • Strategic Planning
• Excellent Communication Skills • Team Player and Leader • Project Management

SELECTED ACHIEVEMENTS

A. Regulatory Compliance

Quality Assurance Consultant, Regulatory Compliance Specialist, ASQ certified Quality Biomedical Auditor (QBA), and FSPCA certified Preventive Controls Qualified Individuals (PCQI) (for past 10+ years, since 2006) for various food, tobacco product, biologic, pharmaceutical, and medical device manufacturers (including combination product manufacturers), including:
• Conducts first party (internal), second party (supplier), and 3rd party (mock, specialized, trace-back, and process) audits, investigations, and gap analyses of quality system and regulatory operations using FDA and various international laws, regulations, directives, standards, and guidance, including 21 CFR 3 & 4 (combination product), 21 CFR 11 (electronic records and signatures), 21 CFR 50-58 & 812-814 (BIMO), 21 CFR 110 (food GMP), 21 CFR 210/211 (drug cGMP), 21 CFR 604 (biologic GMP), 21 CFR 803 (MDR), 21 CFR 806 (CAR), 21 CFR 807 (registration and listing), 21 CFR 809 (IVD), 21 CFR 820 (QSR), 21 CFR 821 (Tracking), EU Active Implant Device Directive (AIDD, EU In-Vitro Diagnostic Directive (IVDD), EU Medical Devices Directive (MDD), EU Medical Device Regulation (MDR), Canadian SOR.98-282, Japanese JQMS MHLW Ordinance #169, Brazilian Resolution No 59, Chinese SFDA GMP for Medical Device #833, and Australian Therapeutic Goods (Medical Devices) Regulations # 236, and various US and international standards and guidance documents, including ISO 13485 & ISO 14971, EU’s MEDDEV 2.12-1, and FDA’s IOM, QSIT, RPM, and compliance programs (such C/Ps 7348.808, 7348.811, 7383.001, and 7382.845).
• Provides regulatory, quality, and technical expertise to top management.
• Directs mock/internal/external FDA QSR, product, and process audits and investigations of manufacturing facilities, including corporate audits of subsidiaries and divisions, within the medical device, pharmaceutical, biologics, and tissue realms.
• Performs gap analysis and initial qualification of GLP facilities for USA Sponsor-Monitor of investigational device exemption (IDE) medical device using FDA laws and regulations.
• Facilitates training sessions related to regulatory, compliance, quality, and auditing to top management, and to the quality, engineering/research and development (R&D), and production departments.
• Analyzes business, legal, quality, sterilization, and nonconformance data associated with orthopedic implant MDR claims made by another orthopedic implant competitor.
• Performs various reconciliation activities, including corrective action planning, procedural reviews, auditing, procedural revisions, and training.
• Serves as resource for customized marketing research in industries or areas related to FDA medical device quality systems, governmental registration process, international business, and QSR/cGMP.
• Performs and/or assists in FDA Warning Letter and Consent Decree reconciliations, including food sanitation, drug cGMP, and medical device quality system (such as design control, change management, and CAPA system) corrections.
• Provides expert quality and regulatory expertise to various industry and legal personnel pertaining to adulterated/ misbranded/ non-conforming medical devices and non-compliant quality systems.
• Performs and/or assists in various front-room and back room inspectional readiness activities prior to, during, and after FDA medical device inspections at U.S. and foreign medical device facilities.
• Acts as a FDA medical device quality assurance and regulatory compliance expert in various legal cases.
• Oversees, monitors, and maintains product and quality system failure investigations, nonconformances, complaints/medical device reports, and Corrective Action/Preventive Action (CAPA) programs
• Reconciles and analyzes numerous quality system procedures and data
• Writes and revises top- and mid-level written procedures
• Trains various governmental and industry personnel in various areas of medical device quality, quality system, quality auditing, design control, CAPA system, and documentation and change control
• Has internal working of FDA field and headquarter offices (including ORA and CDRH)

(Selected Achievements continued on the next page)

Analyst/ Level II certified International Medical Device Investigator for the FDA (for 21+ years up to 2006), including:
• Conducted routine inspections of domestic and foreign manufacturing facilities and investigated consumer complaints related to FDA-regulated products, primarily within the medical device industry.
• Performed full foreign medical device inspections for over 10 years at sites manufacturing all classes and types of medical devices located throughout Asia, Canada, and Europe.
• Advised industry, state, and local officials and consumers on enforcement policies.
• Led training sessions on inspection and investigation techniques and other related topics.
• Served as subject matter expert on all provisions of the Federal Food, Drug, and Cosmetic Act.
• Conducted all types of independent inspections and investigations with minor or no supervisory guidance. The knowledge and experience to conduct all types of inspections and investigations meeting FDA requirements. These inspections included complex, unusual and intricate manufacturing processes, dealing with uncooperative firm managers and personnel. Successfully collaborated with other agencies including local, state, and federal to meet FDA guidelines.
• Collaborated and managed all types of medical device inspections and investigations, including inspections conducted the FDA. Participated in the Agency’s Foreign Inspection Program, concentrating in the medical device area.
• Managed food sanitation, drug, cosmetic and medical device inspections and various investigations including complaint follow-ups, recall audit checks, and undercover buys. Responsible for independently conducting all import operations at this resident post with no supervisory guidance.
• Trained various local, state and federal investigators in food sanitation, medical device, biologic and drug inspectional techniques and in import operations. Worked independently and have become familiar computer operations. Involved in classroom and OJT training of peers and lower level district employees in the medical device area. Mentored lower level employees in the medical device area.
• Recommended to regional and district management officials as to whether or not a firm / individual involved in the production, control, and testing of medical devices and diagnostic products is in compliance regarding Current Good Manufacturing Practices (CGMP). Analyzed reports of inspections and investigations for violations and determine the sufficiency of evidence.
• Managed the review of previously approved products to determine whether they should continue to be permitted in light of current scientific safety data. Coordinated the collection of data, managed a scientific review, and recommended a course of action, such as product guideline performance test standards and product recalls.
• Developed and implemented formal training programs for Agency personnel and provided technical expertise to industry representatives. Conducted on-the job training for Consumer Safety Officers and others and other training for investigators, supervisors, compliance officers, district personnel, and industry regarding technical and scientific matters, inspectional / investigational issues, policies, and laws affecting the medical device program.












REGULATORY COMPLIANCE SKILLS
• Audit, review, and critique most lean related quality system, manufacturing, testing, and design technologies.
• Perform regulatory compliance data reconciliations and documentation and change control and FDA classification, registration, and listing operations.
• Skilled in quality and business concepts, including quality systems and international business management.
• Revise, prepare, audit, review and critique QA (quality assurance) and QC (quality control) programs and documentation to ensure quality production.
• Provide QA/ QC, manufacturing. and test support for manufacturing, floor, and contract vendor production lines.
• Provide information and support for ongoing product design and new product design review boards.
• Audit, review and critique all quality system procedures, records, protocols, reports, and other quality and regulatory documentation [including QMs (quality manuals), SOPs (Standard Operating Procedures), WIs (Work Instructions), and master quality procedure system forms and templates] associated with the QMS (quality management system), management controls, design controls, purchasing controls, material controls, equipment controls, the CAPA system, production and process controls, document, design, and process controls and change management activities, and various process validation activities [including prospective validation IQ (installation qualification), OQ (operation qualification), PQ (process performance qualification), and PPQ (product performance qualification) areas, and concurrent and retrospective related validation protocols, reports, and other documentation].
• Audit, review and critique all QC and manufacturing related protocols and documentation.
• Audit, review and critique Risk Management program and deliverables [such as FME(C)A’s (failure mode, effects, (and criticality) analyses), FTA’s (fault tree analyses), etc.].
• Audit, review and critique manufacturing program procedures, sampling, and processes.
• Participate and represent Regulatory Compliance in various Design, Quality, Regulatory, and Manufacturing meetings (such as pertaining to post-market assessment and surveillance activities, material reviews, nonconforming product and process identifications, evaluations, dispositions, control, corrections, corrective actions, and/or preventive actions).
• Knowledgeable in various domestic and international laws, regulations, directives, standards, and guidance (including FDA, Health Canada, EU, Australian, Brazilian, Japanese, and Chinese medical device and combination product requirements).
• Train and Qualify quality, regulatory, operational/ production, and administrative personnel related to the design, manufacturing and test processes and other quality system requirements.
• Work with ISO/EU/CE Mark, FDA, Health Canada, and other public health and industry personnel, documentation, systems, operations, and requirements.
• Revise, prepare, audit, review and critique Multi-level SOP, BOM (bill of material), and ECO (engineering change order) process instructions and records.
• Audit, review and critique SPC (statistical process control) and QC/QA related protocol and documentation.
• Skilled in New Product Introduction (NPI) and CE mark certification processes.
• Audit, review and critique validation SOPs and policies according to cGMPs (current good manufacturing processes) for aseptic process validation, sterilization validation (steam, gamma, EtO, dry heat, chemical, etc.).
• Audit, review and critique large and small subsidiaries and vendors for set-up and transfer of products to headquarters and vendor sites.
• Audit, review and critique schematics, blueprints and build instructions for various medical devices, including in-vitro diagnostics, orthopedic, electrical and mechanical devices.
• Audit, review and critique purchasing control records and operations and software and hardware validations.
• Audit, review and critique Failure mode effect analysis of product design specifications and documentation.
• Monitor, maintain, audit, review and critique Corrective action and process document processes.
• Audit, review and critique Design review FME(C)As, FTAs, and other risk analysis tools and corresponding risk management activities, processes, and documentation for new and revised product design analyses.
• Audit all major inspection, measurement, and test equipment (such as scopes, logic analyzers, spectrum analyzers, etc.).
• Audit all major production equipment (such as CNC machines, packaging machines, sterilizers, etc.).

REGULATORY COMPLIANCE EXPERTISE
All Types of Class I/III Medical Devices, Including Electronic, Mechanical, and Non-Mechanical Medical Devices- Durable, Electronics, Implantables, IVDs (In-Vitro Diagnostics), Lasers, Software, Cataract systems, Oncology systems, Coated Stents, Steerable Catheters, Over the wire (OTH), Rapid Exchange (RX) Stent delivery systems (STS), Pacemakers, Tracheostomy Tubes, Sterilized Devices, and Orthopedic Implants. Adverse Event Evaluation, Audits -Certification/Due Diligence/ GCP/ GLP / ISO/Quality System Inspection Technique (QSIT)/ Quality System Regulation (QSR), Clinical Labeling / Research/ Study design, Electronic Records & Electronic Signatures; 21 CFR Part 11, FDA, FDA - 483 and Warning Letter Responses/Consent Decree, GMP, Hazard Analysis, ISO - 13485/ 9001/9002/ 9003/14971 (Risk Management), EU Active Implantable Medical Device Directive (AIMD) / EU In-vitro Diagnostic Directive/ EU Medical Device Directive (MDD)/ EU Medical Device Regulation (MDR), Regulatory Compliance, Quality Assurance, Quality Control, Quality Management, Quality Systems Development/ Implementation, and Working Knowledge of FDA Field and HQ Staff, Websites, Databases, Procedures, and Operations.

EMPLOYMENT HISTORY
Independent (Temporary) Contract Positions

Education

November 2017- March 2018. South Bend Career Academy/ South Bend Success Academy, South Bend, IN
Fieldwork Teacher and Substitute Teacher- Secondary Education, Business and Technology
February 2018- April 2018- South Bend Success Academy: Fieldwork Teacher- 9th-10th grade Business (Personal Financial Responsibility)
• Performed various teaching tasks as a secondary education educator in learning, including:
o Created and implemented lesson plans in a manner that ensures the integrity of academic time and motivates students to learn and participate.
o Instructed students regarding a variety of classroom topics and courses of instruction.
o Assigned reasonable tasks and homework to students in accordance with the lesson plans.
o Addressed the various learning styles of students accordingly.
o Modeled correct use of spoken and written English language.
o Demonstrated professional practices in teaching.
o Maintained classroom control that fosters a safe, positive environment for all students and staff in accordance with school, state, and all applicable laws and regulations.
o Ensured adequate supervision of students and the classroom environment to assure the health, welfare, and safety of all students.
o Toom all necessary and reasonable precautions to protect equipment, materials, and school property.
o Remained in the classroom and monitor students at all times.
o Reported all student injuries, accidents, illnesses, and discipline problems to school personnel immediately.
o Supervised students in out-of-class settings (e.g., assemblies, lunchroom, schoolyard).

January 2018 South Bend Career Academy: Substitute Teacher- 9th- 12th grades (including Economics, Marketing & Entrepreneurship, and Personal Finance Responsibility)
South Bend Success Academy: Substitute Teacher- PE and Computer Lab (K-5th Grades)
• Performed various substitute teaching tasks as a secondary education educator, including:
o Implemented existing lesson plans in a manner that ensures the integrity of academic time and motivates students to learn and participate.
o Instructed students regarding a variety of classroom topics and courses of instruction.
o Followed lesson plans as required by school.
o Assigned reasonable tasks and homework to students in accordance with the lesson plans.
o Addressed the various learning styles of students accordingly.
o Modeled correct use of spoken and written English language.
o Demonstrated professional practices in teaching.
o Maintained classroom control that fosters a safe, positive environment for all students and staff in accordance with Kelly Services, school, state, and all applicable laws and regulations.
o Ensured adequate supervision of students and the classroom environment to assure the health, welfare, and safety of all students.
o Took all necessary and reasonable precautions to protect equipment, materials, and school property.
o Remained in the classroom and monitor students at all times.
o Reported all student injuries, accidents, illnesses, and discipline problems to school personnel immediately.
o Supervises students in out-of-class settings (e.g., assemblies, lunchroom, schoolyard).
















December 2017- Present School City of Mishawaka, Mishawaka, IN
Substitute Teacher- Secondary Education
January 2018- Substitute Teacher- 9th-12th Grade (including College and Careers, Business Math, Marketing, Hospitality and Tourism Marketing, English, Chemistry, Nutrition and Health, Physical Education and Health, and World History)
• Performs various substitute teaching tasks as a secondary education educator (to be conducted at a later date), including:
o Implements existing lesson plans in a manner that ensures the integrity of academic time and motivates students to learn and participate.
o Instructs students regarding a variety of classroom topics and courses of instruction.
o Follows lesson plans as required by school.
o Assigns reasonable tasks and homework to students in accordance with the lesson plans.
o Addresses the various learning styles of students accordingly.
o Models correct use of spoken and written English language.
o Demonstrates professional practices in teaching.
o Maintains classroom control that fosters a safe, positive environment for all students and staff in accordance with school, state, and all applicable laws and regulations.
o Ensures adequate supervision of students and the classroom environment to assure the health, welfare, and safety of all students.
o Takes all necessary and reasonable precautions to protect equipment, materials, and school property.
o Remains in the classroom and monitor students at all times.
o Reports all student injuries, accidents, illnesses, and discipline problems to school personnel immediately.
o Supervises students in out-of-class settings (e.g., assemblies, lunchroom, schoolyard).

December 2017- January 2018 Penn-Harris-Madison School District, Mishawaka, IN
Substitute Teacher- Secondary Education
January 2018- Substitute Teacher- 10th Grade English
• Performed various substitute teaching tasks as a secondary education educator, including:
o Implemented existing lesson plans in a manner that ensures the integrity of academic time and motivates students to learn and participate.
o Instructed students regarding a variety of classroom topics and courses of instruction.
o Followed lesson plans as required by school.
o Assigned reasonable tasks and homework to students in accordance with the lesson plans.
o Addressed the various learning styles of students accordingly.
o Modeled correct use of spoken and written English language.
o Demonstrated professional practices in teaching.
o Maintained classroom control that fosters a safe, positive environment for all students and staff in accordance with school, state, and all applicable laws and regulations.
o Ensured adequate supervision of students and the classroom environment to assure the health, welfare, and safety of all students.
o Took all necessary and reasonable precautions to protect equipment, materials, and school property.
o Remained in the classroom and monitor students at all times.
o Reported all student injuries, accidents, illnesses, and discipline problems to school personnel immediately.
o Supervised students in out-of-class settings (e.g., assemblies, lunchroom, schoolyard).

Note: I have been granted a Substitute Teacher Permit from the Indiana Department of Education Indiana Department of Education (approved on November 20, 2017) am currently pursuing an Instructional Emergency Permit from the Indiana Department of Education.















Regulatory Compliance

(With Specific Projects Listed Underneath Applicable Consulting and/or Recruiting Companies)

August 2017- Present CfPA - The Center for Professional Advancement, East Brunswick, NJ
CONTRACT CfPA COURSE DIRECTOR/ MEDICAL DEVICE REGULATORY COMPLIANCE AND QUALITY ASSURANCE CONSULTANT
• Provides professional level accredited and continuing education training in a variety of course formats, including in person, customized client site, and interactive online, pertaining to various up-to-date medical device, pharmaceutical, biologic, combination product, and clinical technical, quality, regulatory, legal, governmental, industry, academic, and business subjects to individual, corporate, legal, and governmental clients when requested and as needed.
Public Training: Quality Management and Compliance in the Pharmaceutical and Related Industries
September 2017, Burlingame, CA
• Provided technical quality system training in the area of pharmaceutical and medical device quality management and compliance to interested clients.

July 2017- Present EAS Consulting Group, LLC, Alexandria, VA
INDEPENDENT MEDICAL DEVICE REGULATORY COMPLIANCE AND QUALITY ASSURANCE CONSULTANT
• To provide various professional up-to-date medical device, pharmaceutical, biologic, combination product, and clinical technical, quality, regulatory, legal, governmental, industry, academic, and business guidance, mentoring, and training to corporate, legal, and governmental clients when requested and as needed. (To be conducted at a later date.)
• To provide various professional regulatory compliance and quality assurance consulting and contracting activities as a Medical Device and Combination Product Quality Systems Subject Matter Expert to corporate, legal, and governmental clients when requested and as needed. (To be conducted at a later date.)
Webinar: Medical Device Quality Auditing
December 2017
• Provided webcast medical device quality auditing training to interested parties.

August 2017 – Present The Windshire Group LLC, Woburn, MA
CONTRACT REGULATORY COMPLIANCE AND QUALITY ASSURANCE CONSULTANT
• Provides professional training and consulting to corporate, legal and government clients as a Medical Device and Combination Products Consultant when requested and as needed.
Webinars: FDA Warning Letters: Remediation Strategies Expert Panel Discussion & CAPA Remediation Strategies
August 2017- September 2017
• Provided online technical panel discussion FDA warning letter reconciliation training to interested parties.
• To provide online technical FDA warning letter reconciliation training primarily in the area of the Medical Device CAPA system to interested parties. (To be conducted at a later date.)

December 2016- June 2017 FARLA Medical, London, UK
REGULATORY COMPLIANCE AND QUALITY ASSURANCE CONSULTANT/ FARLA QUALITY AND REGULATORY MANAGER
Medical Device, Pharmaceutical, and Combination Product Own Label Product Distributor and Manufacturer/ Contract Manufacturer: FARLA Medical, London, UK
• Determined FDA classification and regulatory scheme for various finished medical devices to be marketed in the US.
• To perform various regulatory compliance and quality assurance activities (such as noted below) as FARLA’s Quality and Regulatory Manager (To be conducted at a later date.)
o To work with FDA Quality and Regulatory Consultants LLC (Cedar Park, TX) and AUK Technical Services LLC (Hudson, MI) so that applicable 510(k)s, NDAs, and/or ANDAs can be submitted to the FDA for various class 2 medical devices, combination products, and pharmaceuticals (To be conducted at a later date.)
o To register the company and list the applicable medical devices, combination products, and pharmaceuticals with the FDA via FURLS (To be conducted at a later date.)
o To oversee all quality and regulatory operations (including acting as the company’s management representative, overseeing and/or performing quality audits and gap analyses of the company’s quality system, etc.) (To be conducted at a later date.)
Note: As of June 2017, the above FARLA project has been placed on hold by company management.






February 2016 – Present ComplianceIQ (aka ProForte), San-Bruno, CA
CONTRACT REGULATORY COMPLIANCE AND QUALITY ASSURANCE CONSULTANT
• Provides professional training and consulting to corporate, legal and government clients as a Medical Device Consultant when requested and as needed.
Webinar: Basics of Medical Device Document and Change Controls
July 2016
• Provided online technical quality system training in the area of Medical Device Document and Change Controls to interested clients.

November 2015- December 2015 TSK Laboratory, Japan, Tochigi-Shi, Japan and Tochigo Seiko Co., Ltd., Tochigi-City, Japan
CONTRACT MEDICAL DEVICE REGULATORY COMPLIANCE AND QUALITY ASSURANCE CONSULTANT
Medical Device Manufacturer: TSK Laboratory, Japan, Tochigi-Shi, Japan and Contract Manufacturer: Tochigo Seiko Co., Ltd., Tochigi-City, Japan
• Supplied various medical device quality assurance and regulatory compliance guidance and assistance when requested.
• Performed various reconciliation/ FDA readiness activities associated with upcoming FDA level II QSIT inspection.
• Revised/ created quality system procedures using FDA laws, regulations, standards, and guidance documents.
• Supplied various medical device quality assurance and regulatory compliance training, guidance and assistance when requested.
• Trained company engineering, production, and regulatory/quality department personnel in various medical device quality, regulatory compliance, and quality system requirements (including FDA and EU laws, directives, regulations, and standards, design controls, CAPA system, document and change controls, and facility and material controls)
• Performed mock FDA level II QSIT Audit per FDA laws, regulations, standards, and guidance documents.
• Assisted with various FDA readiness activities, including overseeing QSIT subsystem teams, facility revisions, and procedural and document revisions.
• Assisted in various FDA inspection backroom activities (including subject matter expert coaching).

October 2015- Present Pharmabiodevice Consulting LLC, Rockville, MD
CONTRACT MEDICAL DEVICE REGULATORY COMPLIANCE AND QUALITY ASSURANCE CONSULTANT
• To provide various professional up-to-date medical device, pharmaceutical, biologic, combination product, and clinical technical, quality, regulatory, legal, governmental, industry, academic, and business guidance, mentoring, and training to corporate, legal, and governmental clients when requested and as needed. (To be conducted at a later date.)
• To provide various professional regulatory compliance and quality assurance consulting and contracting activities as a Medical Device and Combination Product Quality Systems Subject Matter Expert to corporate, legal, and governmental clients when requested and as needed. (To be conducted at a later date.)

October 2015- Present SkillsAlliance, London, UK
CONTRACT MEDICAL DEVICE REGULATORY COMPLIANCE AND QUALITY ASSURANCE CONSULTANT
• Provides various professional up-to-date medical device, pharmaceutical, biologic, combination product, and clinical technical, quality, regulatory, legal, governmental, industry, academic, and business guidance, mentoring, and training to corporate, legal, and governmental clients when requested and as needed.
• Provides various professional regulatory compliance and quality assurance consulting and contracting activities as a Medical Device and Combination Product Quality Systems Subject Matter Expert to corporate, legal, and governmental clients when requested and as needed.
Medical Device Manufacturer and Contract Manufacturer: TSK Laboratory, Japan, Tochigi-Shi, Japan and Tochigo Seiko Co., Ltd., Tochigi-City, Japan
October 2015
• Performed various reconciliation/ FDA readiness activities associated with upcoming FDA level II QSIT inspection.
• Revised/ created quality system procedures using FDA laws, regulations, standards, and guidance documents.
• Supplied various medical device quality assurance and regulatory compliance training, guidance and assistance when requested.
• Trained company engineering, production, and regulatory/quality department personnel in various medical device quality, regulatory compliance, and quality system requirements (including FDA and EU laws, directives, regulations, and standards, design controls, CAPA system, and document and change controls)
• Performed mock FDA level II QSIT Audit per FDA laws, regulations, standards, and guidance documents.





August 2015 – Present Compliance2Go, Houston, TX
CONTRACT REGULATORY COMPLIANCE AND QUALITY ASSURANCE CONSULTANT
• Provides professional training and consulting to corporate, legal and government clients as a Medical Device Consultant when requested and as needed.
Webinar: Medical Device Quality, Quality Systems, and Regulatory Compliance
August 2016
• Provided online technical quality system training in the area of Medical Device Quality, Quality Systems, and Regulatory Compliance to interested clients.

June 2015- Present McKinsey & Company, Chicago, IL
CONTRACT MEDICAL DEVICE REGULATORY COMPLIANCE AND QUALITY ASSURANCE CONSULTANT
• To provide various professional up-to-date medical device, pharmaceutical, biologic, combination product, and clinical technical, quality, regulatory, legal, governmental, industry, academic, and business guidance, mentoring, and training to corporate, legal, and governmental clients when requested and as needed. (To be conducted at a later date.)
• To provide various professional regulatory compliance and quality assurance consulting and contracting activities as a Medical Device and Combination Product Quality Systems Subject Matter Expert to corporate, legal, and governmental clients when requested and as needed. (To be conducted at a later date.)

June 2015- Present PricewaterhouseCoopers LLP (PWC), Chicago, IL
CONTRACT MEDICAL DEVICE REGULATORY COMPLIANCE AND QUALITY ASSURANCE CONSULTANT
• To provide various professional up-to-date medical device, pharmaceutical, biologic, combination product, and clinical technical, quality, regulatory, legal, governmental, industry, academic, and business guidance, mentoring, and training to corporate, legal, and governmental clients when requested and as needed. (To be conducted at a later date).
• To provide various professional regulatory compliance and quality assurance consulting and contracting activities as a Medical Device and Combination Product Quality Systems Subject Matter Expert to corporate, legal, and governmental clients when requested and as needed. (To be conducted at a later date.)

April 2015- Present Neozene, Inc., Oakland, CA
PRIMARY MEDICAL DEVICE REGULATORY COMPLIANCE AND QUALITY ASSURANCE CONSULTANT
• Provides various professional up-to-date medical device, pharmaceutical, biologic, combination product, and clinical technical, quality, regulatory, legal, governmental, industry, academic, and business guidance, mentoring, and training to corporate, legal, and governmental clients when requested and as needed.
• Provides various professional regulatory compliance and quality assurance consulting and contracting activities as a Medical Device and Combination Product Quality Systems Subject Matter Expert to corporate, legal, and governmental clients when requested and as needed.
Medical Device Manufacturer: Varian Medical Systems, Winnipeg, Manitoba, Canada
April 2015
• Revised purchasing control/ supplier audit quality system procedures using FDA, Health Canada, and EU laws, regulations, directives, standards, and guidance documents.

April 2015 – Present ComplyArena, Exton, PA
CONTRACT REGULATORY COMPLIANCE AND QUALITY ASSURANCE CONSULTANT
• Provides professional training and consulting to corporate, legal and government clients as a Medical Device Consultant when requested and as needed.
Webinar: Corrective Actions and Preventive Action (CAPA) and How to Initiate, Handle, Monitor and Manage? April 2015
• Provided online technical quality system training in the area of Medical Device CAPA system to interested clients.
Webinar: Medical Device Design Controls: How to Handle, Monitor and Manage
June 2015
• Provided online technical quality system training in the area of Medical Device design controls to interested clients.

April 2014- Present Quality Solutions Now, Inc., Emmaus, PA
CONTRACT MEDICAL DEVICE REGULATORY COMPLIANCE AND QUALITY ASSURANCE CONSULTANT
• To provide various professional up-to-date medical device, pharmaceutical, biologic, combination product, and clinical technical, quality, regulatory, legal, governmental, industry, academic, and business guidance, mentoring, and training to corporate, legal, and governmental clients when requested and as needed. (To be conducted at a later date.)
• To provide various professional regulatory compliance and quality assurance consulting and contracting activities as a Medical Device and Combination Product Quality Systems Subject Matter Expert to corporate, legal, and governmental clients when requested and as needed. (To be conducted at a later date.)


March 2014- Present Ivy Tech Community College, Warsaw, IN
CONTRACT REGULATORY COMPLIANCE AND QUALITY ASSURANCE TRAINER
• Provides technical and professional training to corporate, legal and government clients as a Medical Device Consultant when requested and as needed.
Classroom training: Orthopedic Quality Standards and Technical Skills Certificate Program
March 2014
• Provided technical and professional FDA QSR and ISO 13485 Quality System training to interested personnel.

March 2014- Present The CECON Group/ CECON LLC, Wilmington, DE
PRIMARY MEDICAL DEVICE REGULATORY COMPLIANCE AND QUALITY ASSURANCE CONSULTANT
• Provides various professional up-to-date medical device, pharmaceutical, biologic, combination product, and clinical technical, quality, regulatory, legal, governmental, industry, academic, and business guidance, mentoring, and training to corporate, legal, and governmental clients when requested and as needed.
• Provides various professional regulatory compliance and quality assurance consulting and contracting activities as a Medical Device and Combination Product Quality Systems Subject Matter Expert to corporate, legal, and governmental clients when requested and as needed.
• Serves as an expert witness and/or litigation consultant offering expert testimony, expert advice, litigation support, forensic services, and related expert witness services in various litigation areas (such as FDA and/or international Medical Device Quality Systems; Governmental and International Business Operations; Site Registration and Product Listing; Product Classification, Market Submission, Receipt, Acceptance, Design, Manufacturing, Nonconformance, Packaging and Labeling, Storage, Handling, and Distribution; Management Controls, Design Controls, Purchasing Controls, Document and Change Management Controls, Material Controls, Facility Controls, Equipment Controls, Production and Process Controls, and other quality, regulatory, and legal QSR/cGMP requirements).
Law Office (Confidential), Glendora, CA May 2017- Present
• Analyzes, investigates, and reviews court records, depositions and associated product servicing et al quality system documentation (including manufacturing company written procedures and quality data) pertaining to the improper servicing of medical device products and corresponding quality system procedures and quality records.
• Additional activities to be determined at a later date.
Law Office (Confidential), Winchester, MA May 2017- Present
• Analyzes, investigates, and reviews court records, depositions and associated product labeling/ storage/ handling/ et al quality system documentation (including manufacturing company written procedures and quality data) pertaining to the improper storage and handling of medical device products and corresponding quality system procedures and quality records.
• Additional activities to be determined at a later date.
Law Office (Confidential), Houston, TX January 2017- Present
• Analyzes, investigates, and reviews court records, depositions and associated CAR/ MDR/ complaint/ et al quality system documentation (including FDA MAUDE reports, 483’s, and warning letters and manufacturing company written procedures and quality data) pertaining to non-conforming medical device products and corresponding quality system procedures and quality records.
• Additional activities to be determined at a later date.
Law Office (Confidential), North Haven, CT June 2016- June 2017
• Analyzed, investigated, and reviewed court records, depositions and associated CAR/ MDR/ complaint/ servicing, et al quality system documentation (including FDA 483’s, warning letters, and consent decrees) pertaining to non-conforming medical device products and corresponding quality system procedures and quality records.

February 2014 – Present Compliance Online, Palo Alto, CA
CONTRACT REGULATORY COMPLIANCE AND QUALITY ASSURANCE CONSULTANT
• Provides professional training and consulting to corporate, legal and government clients as a Medical Device Consultant when requested and as needed.
Webinar: Basic Medical Device CAPA (Corrective Action and Preventive Action) System Concepts
February 2014
• Provided online technical quality system training in the area of Medical Device CAPA system to interested clients.









January 2014- Present Adecco Staffing, Indianapolis, IN
CONTRACT MEDICAL DEVICE QUALITY ASSURANCE AND REGULATORY COMPLIANCE EXPERT
• Provides various professional up-to-date medical device, pharmaceutical, biologic, combination product, and clinical technical, quality, regulatory, legal, governmental, industry, academic, and business guidance, mentoring, and training to corporate, legal, and governmental clients when requested and as needed.
• Provides various professional regulatory compliance and quality assurance consulting and contracting activities as a Medical Device and Combination Product Quality Systems Subject Matter Expert to corporate, legal, and governmental clients when requested and as needed.
Medical Device Manufacturer: Zimmer USA, Warsaw, IN
January 2014
• Reconciled medical device design history files using FDA laws, regulations, and guidance documents.

November 2013 Signature Orthopaedics Pty, Sydney, Australia
CONTRACT MEDICAL DEVICE QUALITY ASSURANCE AND REGULATORY COMPLIANCE EXPERT
• Supplied various medical device quality assurance and regulatory compliance guidance and assistance when requested.
• Provided import training to various site personnel (online training via GO-TO-MEETING).

October 2013- Present Regulatory Compliance Associates, Inc., Pleasant Prairie, WI
CONTRACT REGULATORY COMPLIANCE AND QUALITY ASSURANCE CONSULTANT
• Provides various professional up-to-date medical device, pharmaceutical, biologic, combination product, and clinical technical, quality, regulatory, legal, governmental, industry, academic, and business guidance, mentoring, and training to corporate, legal, and governmental clients when requested and as needed.
• Provides various professional regulatory compliance and quality assurance consulting and contracting activities as a Medical Device and Combination Product Quality Systems Subject Matter Expert to corporate, legal, and governmental clients when requested and as needed.
Medical Device Manufacturer: Ad-Tech Medical Instrument Corporation, Racine, WI
October 2013
• Conducted quality plan reconciliation and improvement using FDA laws, regulations, and guidance documents.

August 2013 - Present Validant, Inc., San Francisco, CA
CONTRACT REGULATORY COMPLIANCE AND QUALITY ASSURANCE CONSULTANT
• Provides various professional up-to-date medical device, pharmaceutical, biologic, combination product, and clinical technical, quality, regulatory, legal, governmental, industry, academic, and business guidance, mentoring, and training to corporate, legal, and governmental clients when requested and as needed.
• Provides various professional regulatory compliance and quality assurance consulting and contracting activities as a Medical Device and Combination Product Quality Systems Subject Matter Expert to corporate, legal, and governmental clients when requested and as needed.
Medical Device Manufacturer: EKOS, Inc., Bothell, WA
September 2013
• Conducted external mock FDA QSIT inspection using FDA laws, regulations, and guidance documents.

August 2013 – September 2013 Compliance Architects, Robbinsville, NJ
CONTRACT REGULATORY COMPLIANCE AND QUALITY ASSURANCE CONSULTANT
• Provided professional auditing as a contract Medical Device Quality Systems Auditor.
Contract Medical Device Manufacturer: Medicia, Dayton, NJ
September 2013
• Conducted external mock FDA QSIT inspection using FDA laws, regulations, and guidance documents.

June 2013 – Present PSC Creative Learning, Pomona, CA
CONTRACT REGULATORY COMPLIANCE AND QUALITY ASSURANCE CONSULTANT
• Provides technical training & professional consulting to corporate, legal and government clients as a Medical Device Consultant when requested and as needed.
Webinar: Understanding and Performing Medical Device Internal and External Quality Audits (Parts 1 & 2)
June & July 2013
• Provided online technical quality system training in the area of 1st, 2nd, & 3rd Party Quality Audits to interested clients.






June 2013 – Present AUK Technical Services LLC
QUALITY DIRECTOR
• Provides various professional up-to-date medical device, pharmaceutical, biologic, combination product, clinical, food, cosmetic, and tobacco product technical, quality, regulatory, legal, governmental, industry, academic, and business guidance, mentoring, and training to corporate, legal, and governmental clients when requested and as needed (including various contract work for/at Hudson Scientific and Chemular).
• Provides various professional regulatory compliance and quality assurance consulting and contracting activities as a Medical Device, Pharmaceutical, Biologic, Combination Product, Food, Cosmetic, and Tobacco Product Quality Systems Subject Matter Expert to corporate, legal, and governmental clients when requested and as needed (including various contract work for/at Hudson Scientific and Chemular).
• Acts as a Medical Device Quality and Regulatory Manager and Management Representative, Pharmaceutical and Biologic Quality Assurance Manager, and Food Preventive Controls Qualified Individual for various clients when requested and as needed.

Work Performed for AUK Related Companies

E-cigarette Consulting Company: Chemular Inc., Hudson, MI
June 2016- August 2018
CONTRACT REGULATORY COMPLIANCE AND QUALITY ASSURANCE CONSULTANT
• Worked with other AUK Technical Services management and team members (as contractors and employees for Chemular, Inc.) and various Chemular management and staff to assist US and foreign e-cigarette clients to achieve compliance with industry, FDA and/or EU tobacco product regulations when requested and as needed. (Additional activities to be conducted at a later date.)

Medical Device, Pharmaceutical, and Combination Product Contract Manufacturer and Medical Device Initial Importer: Hudson Scientific LLC, Hudson, MI
February 2016- October 2016 and March 2017- August 2018
DIRECTOR OF REGULATORY AFFAIRS, REGULATORY COMPLIANCE, AND QUALITY ASSURANCE/ MANAGEMENT REPRESENTATIVE
• Acted as Director of Regulatory Affairs, Regulatory Compliance, and Quality Assurance/ Management Representative from March 2018- August 2018 (performed remotely at residence and at Hudson, MI).
• Acted as Quality and Regulatory Manager from September 2016- October 2016 (performed remotely at residence and at Hudson, MI).
• Conducted various regulatory affairs, regulatory compliance, and quality assurance activities and assisted onsite staff as needed and required (performed remotely at residence and at Hudson, MI), including:
o Assisted company management and staff during an initial FDA cGMP pharmaceutical inspection.
o Performed various regulatory affairs, regulatory compliance, and quality assurance work and assists onsite staff as needed and required.
o Worked with other AUK Technical Services team members (as contractors and employees for Hudson Scientific) and various full-time and contract/ temporary Hudson management and staff to assist with start-up and continued operations so that the contract manufacturing company was following applicable FDA medical device, pharmaceutical, and combination product laws and regulations.
 Oversaw and performed the creation of draft quality system procedures.
 Advised company engineering and production department personnel in FDA medical device, pharmaceutical, and combination product requirements.
o Trained company engineering, production, and quality department personnel in various medical device quality, regulatory compliance, and quality system requirements (including FDA and EU laws, directives, regulations, and standards, design controls, CAPA system, and document and change controls).
o Performed 1st, 2nd, and 3rd party audits and gap analyses.
o Reviewed current quality system procedures and quality records for compliance against FDA medical device, pharmaceutical, and combination product laws and regulations.
o Trained, mentored, guided, and/or coached Hudson management and staff in current industry, FDA, and international medical device, pharmaceutical, and combination product laws, regulations, directives, standards, guidance, and requirements.
o Individually and/or with the assistance of Hudson management and/or staff, performed, oversaw, and/or managed nonconforming and out of specification medical device, pharmaceutical, and combination product, quality system, and process corrections, corrective actions, preventive actions.
o Individually and/or with the assistance of Hudson management and/or staff, performed, oversaw, and/or managed applicable medical device, pharmaceutical, and combination product document, design, and/or process changes (including new products and operations).

(Continued on the next page)
o Liaised with Hudson management and staff prior to, during and after all FDA, OEM, customer, and other regulatory body and industry quality and regulatory inspections, investigations, audits, and gap analyses, including applicable front and/or back room FDA inspectional readiness activities.

Independent Projects Performed as AUK’s Quality Director

Medical Device Specification Developer: iTOVi, Lindon, UT
April 2018- August 2018
• Oversaw and performed 21 CFR 803 MDR (medical device reporting) and 21 CFR 806.10 product removal operations for an unapproved, adulterated, and misbranded FDA class 2 medical device.
• Worked with other AUK Technical Services team members to transfer various specification developer operations to Hudson Scientific LLC.
• Worked with other AUK Technical Services team members to assist the company’s design control team with creating design control quality system procedures and a medical device design history file for a ‘redesigned’ FDA class 2 medical device per applicable and current FDA medical device laws and regulations.
• Worked with other AUK Technical Services team members and various company management and staff to assist with operations so that the specification developer follows current and applicable FDA medical device laws and regulations (including developing draft quality system procedures and advising company management and personnel in current FDA medical device requirements.
Medical Device Manufacturer and Specification Develper: Konsyl Pharmaceuticals, Easton, MD
March 2018- April 2018
• Worked with other AUK Technical Services team members to transfer various manufacturing operations to Hudson Scientific LLC.
• Worked with other AUK Technical Services team members to assist the company’s design control team with creating design control quality system procedures and a medical device design history file for an FDA class 2 medical device per applicable and current FDA medical device laws and regulations.
• Worked with other AUK Technical Services team members and various company management and staff to assist with operations so that the medical device manufacturer follows current and applicable FDA medical device laws and regulations (including advising company management and personnel in current FDA medical device requirements.
Medical Device Manufacturer: Nexgen Dental Milling Center, Santa Fe Springs, CA
November 2017- August 2018
• Worked with other AUK Technical Services team members to prepare and submit an abbreviated 510(k) premarket notification (PMN) submission for an FDA class 2 medical device per applicable and current FDA medical device laws and regulations.
• Worked with other AUK Technical Services team members to assist the company’s design control team with creating design control quality system procedures and a medical device design history file for a FDA class 2 medical device per applicable and current FDA medical device laws and regulations.
• Worked with other AUK Technical Services team members and various company management and staff to assist with start-up operations so that the manufacturing company is in compliance with current and applicable FDA medical device laws and regulations (including developing draft quality system procedures and advising company management and personnel in current FDA medical device requirements. (Additional activities to be conducted at a later date.)
Medical Device Manufacturer: Nasaleze Group, Douglas, IM
September 2017- December 2017
• Worked with other AUK Technical Services team members to assist with various offsite FDA Level 2 QSIT inspection readiness tasks for a medical device manufacturer [including training/ guiding/ coaching management and staff on various quality system areas (such as management controls, design controls, document and change controls, CAPA system, material controls, equipment controls, facility controls, and P&PC), and creating/ revising various quality system documents (such as FDA class 2 510(k) medical device design history files (DHFs) and CAPA/ complaint handling/ medical device reporting (MDR)/ correction and removal (CAR) documents)] per applicable and current FDA medical device laws and regulations.
• Performed an off-site internal quality audit of the company’s quality system procedures and quality documents against FDA laws and regulations and QSIT manual (including quality system procedures, quality records, and other data utilized during the performance of an off-site 3rd party mock FDA QSIT desk audit) per applicable and current FDA medical device laws and regulations and QSIT manual.
o Performed an off-site 3rd party mock FDA QSIT desk-audit of the company’s quality system procedures and quality documents against applicable and current FDA laws and regulations and QSIT manual.

(Additional AUK contract work continued on the next page)



• Medical Device Manufacturer: Pacific Hospital Supply Company, Ltd., Taipei, Taiwan and Miaoli, Taiwan
June 2017 – August 2017
• Worked with other AUK Technical Services team members to assist with Warning Letter reconciliation of a medical device manufacturer, contract manufacturer, and foreign exporter including issuing/ reviewing CAPAs, reviewing/ drafting Warning Letter replies to the FDA, and overseeing/ performing various FDA reconciliation activities (including creating/ revising quality system procedures, and training/ guiding/ coaching management and staff on various quality system areas such as CAPA investigations, CAPA root cause analyses, verification/ validation of CAPA effectiveness, and process validation) (performed onsite and remotely at residence).
Medical Device Specification Developer: MSH Manufacturing LLC, Los Angeles, CA
April 2017
• Worked with other AUK Technical Services team members to revise an abbreviated 510(k) premarket notification (PMN) submission due to various PMN deficiencies noted by FDA CDRH reviewers. (To continue at a later date.)
Medical Device Manufacturer: Abbott Laboratories/ St. Jude Medical, Atlanta, GA
March 2017
• Performed corporate audit of acquired PMA medical device product under FDA and international laws, regulations, directives, standards, guidance, and the QSIT manual.
Medical Device Manufacturer: Aroa Biosurgery, Aukland, NZ
January-February 2017
• Performed desk-audit of device- biologic combination products’ risk documentation against FDA laws and regulations and QSIT manual.
Medical Device Specification Developer: Ultroid Technologies, Inc., Tampa, FL (relocated at Hudson, MI on August 2016) (Out of Business as of October 2016)
February 2016- September 2016
• Worked with other AUK Technical Services team members to assist with Warning Letter reconciliation of a medical device specification developer, including creating quality system procedures, issuing CAPAs, and drafting a Warning Letter reply to the FDA (all performed remotely from residence).
• Oversaw and performed 21 CFR 806 product removal operations.
o Prepared draft 21 CFR 806 product removal report to the FDA.
o Trained and worked with temporary workers in the creation of product/ customer removal list for the FDA.
• Acted as Quality and Regulatory Manager/ Management Representative from August 2016- September 2016 (performed remotely at residence and at Hudson, MI, such as during an FDA inspection).
• Managed product destruction operations at Hudson, MI (September 2016).
o Trained and worked with temporary workers on the identification, nonconformance, storage, and handling of onsite non-conforming products and behavior during FDA inspections and investigations (with the product destruction to be witnessed by the FDA at a later time).
o Prepared and/or oversaw the preparation of nonconforming product records by temporary workers associated with the onsite nonconforming products.
o Prepared destruction written procedures and trained temporary workers on non-conformi

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