Medical Device Quality Assurance Compliance Expert with FDA Employment Experience

Expertise

• Medical Device quality assurance and regulatory compliance professional possessing over 28 years' experience.
• Manufacturing, pharmaceutical, biologic, and medical device operations.
• 21 years of employment with the FDA, primarily as a Medical Device Investigator.
• Professional consulting; FDA Medical Device Quality regulations and FDA compliance.
• ASQ certified, (QBA) medical device regulatory compliance and non-technical quality assurance expert, specializing in medical device quality systems.
• Failure modes and effects analysis of medical devices.
• Metallurgical engineering technology as applied to medical devices.
• Development of medical device quality control procedures and SOPs.
• Training related to FDA medical device compliance and quality regulations; FDA pre audits of a firm's quality, engineering, research and development and production departments.
• Regulatory devices: Non-mechanical medical devices, oncology systems implantables, IVD's, coated stents, rapid exchange stent delivery systems, pacemakers, steerable catheters, all types of class I/III medical devices.
• Regulatory expertise: Quality System Inspection Technique (QSIT), electronic records and electronic signatures, FDA, FDA - 483 and warning letter, OSHA, SO - 13485/ 9001/9002/ 9003/14971, Active Implantable Medical Device Directive (AIMD), Hazard Analysis, 21 CFR Part 11, Regulation (QSR).
• National and international medical device quality assurance and regulatory compliance support in various locations and areas; European, Canadian, Australian, Brazilian, Japanese, and Chinese medical device quality system and clinical laws, regulations, standards, and guidelines.

Expert Witness Experience

• Expert witness related to medical device litigation providing document analysis and review.
• Investigate and review depositions for medical device cases.

Experience

Independent Consultant, 2006 - Present

• Strategy study for importer, distributor and contract medical device manufacturer.
• Gap analysis of quality system written procedures using FDA and EU laws, standards, and regulations for pharmaceutical, biologic and medical device developer.
• Consulting as a FDA Medical Device Quality Systems expert.
• Analyze business, legal, quality, sterilization and non-conformance data associated with orthopedic implant MDR claims made by another orthopedic implant competitor.
• Quality compliance consulting and contracting to medical device manufacturer.
• For dental medical device manufacturer, conducted mock/internal/external FDA/ISO/MDD QSR audits of domestic manufacturing facilities.
• Provided professional consulting as a FDA Medical Device Quality Systems expert on governmental registration process.
• Audit and review written procedures, quality records, quality system records, regulatory submissions, process validations, and design studies to conform to external laws, directives, regulations, standards, and guidance.
• Knowledge of various types of quality system and clinical operations, conduct gap analyses/ data reconciliations, and provide training and guidance to both governmental and industry personnel in these and other pharmaceutical, biologic, and medical device areas.
• Perform 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.
• As expert witness; analyzed, investigated and reviewed documentation, labeling and potential non-conforming combination pharmaceutical and medical device product.
• As expert witness; analyze, investigate and review depositions and associated MDR/ complaint and documentation pertaining to a potential non-conforming surgical medical device product.

Sample Projects

Orthopaedics Pty., Sydney, Australia

• Provided import training to various site personnel (online training via Go-to-meeting).

Ad-Tech Medical Instrument Corporation, Racine, WI

• Conducted quality plan reconciliation and improvement using FDA laws, regulations.

Validant, Inc., San Francisco, CA

• Provides technical consulting to corporate, legal and government clients.
• Provides professional consulting as a Medical Device, Pharmaceutical, and Biologics Quality Systems Consultant.

EKOS, Inc., Bothell, WA

• Conducted external mock FDA QSIT inspection using FDA laws, regulations, and guidance documents.

Compliance Architects, Robbinsville, NJ

• Provided professional auditing as a contract Medical Device Quality Systems Auditor.

Medicia, Dayton, NJ

• Conducted external mock FDA QSIT inspection using FDA laws, regulations, and guidance documents.

PSC Creative Learning, Pomona, CA

• Provides technical training and professional consulting to corporate, legal and government clients as a Medical Device Consultant.

AUK Technical Services LLC, Beverly Hills, CA

• Provides professional consulting as a Medical Device, Pharmaceutical, and Biologics Quality Systems Consultant.

EPRT Technologies, Inc., Simi Valley, CA

• Conducted internal and external auditing using EU and FDA laws, directives, regulations, and standards.
• Performed applicable regulatory compliance and quality assurance activities as required.
• Provided regulatory and compliance expertise to top management and quality and operational departments.

FXI, Inc., Media, PA

• Provides technical consulting to corporate and site management and staff.
• Provides professional consulting as a Medical Device Quality Systems Consultant.
• Performs applicable regulatory compliance and quality assurance.

Employment

VanGo Media, Business and Operations Manager, Gilbert, AZ, 2006 - 2007

• Responsible for all operational, administrative, sales, financial and business functions of a start-up production company.
• Prepared business plans and all internal procedures.
• Applied cooperative teaming and project budget analyses to determine avoidable costs.
• Created policies and procedures for effective management and business development.
• Collaborated with others in the marketing of a television program to potential clients.

U.S. Food and Drug Administration, Chicago, IL, Pittsburgh, PA, South Bend, IN, 1985 - 2006

Analyst Level II Certified International Medical Device Investigator

• Conducted routine inspections of domestic and foreign manufacturing facilities and investigated consumer complaints related to FDA-regulated products, primarily related to medical devices.
• Conducted full foreign medical device inspections for over 10 years at sites manufacturing all classes and types of medical devices and located throughout Canada and Europe.
• Evaluated product designs and manufacturing processes for compliance with regulations.
• Performed and documented numerous inspections, achieving enhanced compliance through various regulatory actions including warning letters and seizures.
• Established continuous process improvement at all levels in organization.
• Extensive background in the enforcement of consumer protection regulations.
• Thorough knowledge of all provisions of the Federal Food, Drug, and Cosmetic Act.
• Experience in both the field ensuring FDA compliance as well as in the headquarters office.
• Worked (internal detail positions) as a field compliance officer, FDA HQ international medical device inspection planner, and FDA HQ International compliance officer.
• Ensured that manufacturers' employees have proper knowledge of applicable regulations.
• Developed and implemented business practices improving and reducing operating expenses.
• Collaborated with manufacturers' personnel to gather information and explain findings.
• Initiated legal actions against violators.
• Conducted training sessions on inspection and investigation techniques and other related topics.
• Communicated with and maintained customer relations.
• Served as team leader on complex assignments requiring the participation of multiple personnel.

Detroit District Medical Device Co., IN, Serving Several Positions, 1996 - 2000

• Level I/II Certified International Medical Device Investigator

Honors & Publications

Credentials

• Level II certified international medical device investigator in the U.S. government or as a contract quality assurance consultant and regulatory compliance specialist in the medical device industry.
• Trainer: Qualify QA, Mfg, Test and Admin personnel related to the manufacturing and test processes.
• Auditor: Review and critique all QSM, SOP, IQ, OQ, PQ, PPQ, and QC Mfg. related protocols and documentation. Risk Management program and deliverables (FMEA's, FTA's, etc.).
• MAC/PC Applications.
• Computer Aided Inspections, Computer Systems Validation, FMEA Workshop, Auditing Medical Devices, Medical Device Process Validation, Quality Audits for Improved Performance, Industrial Sterilization for Drugs/Devices, Orientation to International Inspections.

Education

• M.S. Regulatory Affairs for Drugs, Biologics, and Medical Devices (2017 Spring), Northeastern University, Boston, MA
• MBA International Business, Indiana University, IN
• B.S. Metallurgical Engineering, University of Notre Dame, IN
• B.S. Chemistry, University of Notre Dame, IN