Medical Device Quality Assurance Compliance Expert with FDA Employment Experience

Technical Consultant #1666


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
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