Quality Assurance, Medical Device, Regulatory Compliance, FDA Expert Consultant Resume
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Resume of NII
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  • Quality Assurance
  • Medical Device
  • Regulatory Compliance
  • FDA
  • Biomedical Auditor

PhD, International Business, Walden University (in process of obtaining)

MBA, Concentration in International Business, Indiana University

Bachelor of Science, Metallurgical Engineering, University of Notre Dame

Bachelor of Science, Chemistry, University of Notre Dame

A 27-year food, cosmetic, drug, biologic, clinical, and medical device 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. Over six years of industrial experience as a biologic, pharmaceutical, and medical device industry quality assurance consultant, regulatory compliance specialist, and ASQ certified quality biomedical auditor. 
 
This expert has inspected, investigated, and audited all types of U.S. and foreign food, cosmetic, drug, biologic, medical device, and clinical facilities, andt has also performed various pharmaceutical and medical device quality assurance and regulatory compliance operations. Some examples include 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 EU enforcement policies.    
 
Primary expertise is in medical device quality assurance and regulatory compliance, possessing vast knowledge of U.S., European, Canadian, Brazilian, Japanese, and Chinese medical device quality systems and clinical laws, regulations, standards, and guidelines. Also experienced in the similarities and differences between U.S. food, human and animal pharmaceutical, cosmetic, biologic, tissue, and clinical laws, regulations, guidelines, and operations.
 
A self-starter with good written and oral communications skills and a strong history and proven track record of leading or working with teams. Strives for continuous improvement, consistency in quality assurance and regulatory compliance with reduced waste while auditing, consulting, and contracting medical device, biologic, and pharmaceutical facilities.  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.  Understands the inner workings of the FDA and regulated industry, and also international management operations.  Skills include:
 
  • Audit, review, and critique most lean related manufacturing technologies.
  • Perform regulatory compliance data reconciliations and documentation and change control and FDA listing operations.
  • Skilled in quality and business concepts, including quality systems and international business management.
  • Revise, prepare, audit, review and critique QA and QC programs and documentation to ensure quality production.
  • Provide QA Mfg and test support for Mfg 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 QSM, SOP, EC, IQ, OQ, PQ, PPQ related protocols and documentation.
  • Audit, review and critique all QC Mfg related protocols and documentation.
  • Audit, review and critique Risk Management program and deliverables (FMEA’s, FTA’s, etc.).
  • Audit, review and critique manufacturing program procedures, sampling, and processes.
  • Participate and represent Regulatory in Design and Manufacturing meetings. ECO, DRB, MRB, etc.
  • Knowledgeable in FDA, Health Canada, EU, Brazilian, Japanese, and Chinese medical device regulations.
  • Train and Qualify QA, Mfg, Test and Admin personnel related to the manufacturing and test processes.
  • Work with ISO/EN/CE, FDA, Health Canada, and other Agency documentation and Qualifications.
  • Revise, prepare, audit, review and critique Multi-level SOP, BOM, and ECO process instructions and records.
  • Audit, review and critique SPC 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 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 FMEAs and risk management for product design analysis.
  • Audit all major test equipment (such as scopes, logic analyzers, spectrum analyzers, etc.).
  • Audit all major production equipment (such as CNC machines, packaging machines, sterilizers, etc.).
  • Regulatory expertise in all Types of Class I/III Medical Devices, Including Electronic, Mechanical, and Non-mechanical Medical Devices- Durable, Electronics, Implantables, IVDs, 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)/ Active Implantable Medical Device Directive (AIMD) / In-vitro Diagnostic Directive/ Medical Device Directive (MDD), OSHA, Quality Assurance, Quality Control, Quality Management, Quality Systems Development/ Implementation, Working Knowledge of FDA Operations.

Consultant, Kevin Kennedy Associates, Inc., Indianapolis, IN
Providing food, cosmetic, drug, biologic, clinical, and medical device quality assurance and regulatory compliance expertise to a wide variety of clients.
 
Contract Regulatory Compliance and Quality Assurance Consultant,Compliance Insight, Inc., Fairfield, OH
  • Provide technical consulting to corporate, legal and government clients.
  • Provide professional consulting as a Medical Device, Pharmaceutical, and Biologics
 Quality Systems Consultant,Medical Device Client: Confidential, Manufacturer, USA
  • Conducts QSR audit using FDA laws and regulations.
  • Provides regulatory and compliance expertise to top management and quality and operational departments.
 Contract Regulatory Compliance and Quality Assurance Consultant, Azzur Group Willow Grove, PA 19090
  • Quality Systems Consultant.
            Pharmaceutical Client: Confidential, Manufacturer, USA
  • Performs corporate confirmation, verification, and auditing activities against an FDA consent decree for a MNC subsidiary pharmaceutical company.
  • Provides regulatory and compliance expertise to top management and parent regulatory compliance and subsidiary company departments.
 Medical Device Regulatory Compliance and Quality Assurance Consultant,enKap, West Palm Beach, FL
  • Provides technical training to corporate, legal and government clients.
  • Provides professional training as a Medical Device Quality Systems Consultant.
 Contract Regulatory Compliance and Quality Assurance Consultant, Pathwise, American Fork, UT
  • Provides technical consulting to corporate, legal and government clients.
  • Provides professional consulting as a Medical Device, Pharmaceutical, and Biologics Quality Systems Consultant.
            Medical Device Client: Confidential, Specification Developer/ Manufacturer, USA
  • Conducted IVDD/ MDD/ISO 13485/ QSR audit of quality assurance, regulatory, and design control operations using FDA laws and regulations.
  • Provides regulatory and compliance expertise to top management and quality departments.
            Medical Device Client: Confidential, Contract Manufacturer, USA
  • Conducts MDD/ISO 13485/ QSR gap analysis of documentation and change controls, training, CAPA, process validation, and design control operations and prepared an action plan to correct the identified gaps.
  • Provides regulatory and compliance expertise to top management and quality and engineering departments.
  • Prepares gap analysis correction plan.
  • Assists with the improvement of quality control procedures and SOPs as required.
  • Assists with training sessions related to regulatory, compliance, quality, and auditing to top management, and to the quality, engineering/R&D, and production departments.
  • Conducts internal audits of the quality system.
Contract Medical Device Quality Assurance and Regulatory Compliance Expert, Pan America Hyperbarics, Inc. (PAHI), Richardson, TX and Kaohsiung, Taiwan (CHINA)
  • Supplies various medical device quality assurance and regulatory compliance guidance and assistance when requested.
 Contract Medical Device Quality Expert, Electrika, Inc., Islip Terrance, NY & Somatics, LLC, Lake Bluff, IL
  • Assisted with the correction to FDA 483 observations of the specification developer.
  • Conducted gap analysis of quality system of contract manufacturer using FDA laws and regulations.
  • Assisted with the improvement of quality control procedures and SOPs as required.
  • Provided regulatory, quality, and technical expertise to the top management.
  • Conducted desk audit of the quality system of the contract manufacturer.
  • Prepared written audit correction plan.
  • Performed various audit correction activities, including revising written instructions, revamping the management control, document and change control, quality auditing, purchasing control, CAPA, and production and process control operations.
 Regulatory Compliance Specialist, Biomet, Inc., Warsaw, IN
  • Conducts mock/internal/external FDA QSR, product, and process audits and investigations of domestic manufacturing facilities of Biomet, including corporate audits of subsidiaries and divisions, within the medical device, pharmaceutical, biologics, and tissue realms.
  • Completes quality records and/or prepares written procedures (such as pertaining to design control, servicing, and document and change control written procedures and CAPA reports) when needed or requested.
  • Performs various regulatory compliance activities (such as ‘hands-on’ document and change control administrative activities, FDA product listing activities, and transfer plan reconciliations).
  • Heads or assists with various regulatory compliance and quality projects (such as improving the design control, document and change control and internal audit programs).
  • Evaluates product designs and manufacturing processes for compliance with regulations.
  • Performs onsite reviews of firm written procedures, processes, and operations and where necessary, recommended corrections for continuous improvement.
  • Establishes continuous process improvement at various levels at the organization (such as reconciling product registration, listing, and submission data and preparing various quality and regulatory training presentations).
  • Extensive background in the enforcement of consumer protection regulations.
  • Thorough knowledge of all provisions of the Federal Food, Drug, and Cosmetic (FD&C) Act.
  • Experience in both the FDA field and headquarters offices to ensure compliance prior to FDA inspectional visits. 
  • Knowledge of Medical Device Directives, ISO 13485:2003, Canadian Medical Device Regulations, Japanese Medical Device Regulations, Brazilian Medical Device Regulations, and Chinese Medical Device Regulations.
  • Ensures that manufacturers’ employees have proper knowledge of applicable regulations.
  • Develops and implements business practices improving and reducing operating expenses of company sites (such as supplying solutions to correct any internal and external quality system deviations and preparing various quality system training presentations for future training sessions).
  • Collaborates with site manufacturing personnel to gather information and explain findings.
  • Advises firm officials on current FDA & EU enforcement policies.
  • Conducts informal training sessions on quality, medical device regulations, FD&C law, inspection and investigation techniques and other related topics.
  • Communicates with and maintains customer relations with facility personnel (such as during internal audits of other site locations).
  • Significant experience in making group presentations to firm officials and personnel.
 Contract Medical Device Quality Systems Expert, ADB Consulting & CRO, Inc., Pembroke Pines, FL
  • Provides technical consulting to corporate, legal and government clients.
  • Provides professional consulting as a FDA Medical Device Quality Systems Consultant.
            Medical Device Client: Confidential, GLP Laboratory, USA
  • Conducts gap analysis and initial qualification of GLP facility for USA Sponsor-Monitor of IDE medical device using FDA laws and regulations.
  • Provides regulatory and compliance expertise to top management and quality departments.
 Contract Medical Device Quality Expert, Pan America Hyperbarics, Inc., Kaohsiung, Taiwan (CHINA)
  • Conducted gap analysis of quality system using FDA laws and regulations.
  • Assisted with the development of quality control procedures and SOPs as required.
  • Provided regulatory, quality, and technical expertise to the top management and quality, engineering/R&D, and production departments.
  • Conducted training sessions related to regulatory, compliance, quality, and auditing to top management, and to the quality, engineering/R&D, and production departments.
  • Conducted internal audits of the quality system.
  • Prepared written audit correction plan.
  • Performed various audit correction activities, including revising written instructions, revamping the document and change control, purchasing control, CAPA, and production and process control operations.
 
Contract Medical Device Quality Expert, The FDA Group, Worchester, MA
  • Provided technical consulting to corporate, legal and government clients.
  • Provided professional consulting as a FDA Medical Device Quality Systems Consultant.
      Device Manufacturer: Thermo Fisher Scientific, Middletown, MA
  • Provided guidance of off label requirements using FDA laws and regulations.
            Device Manufacturer: Pan America Hyperbarics, Inc., Kaohsiung, Taiwan (   CHINA)
  • Conducted gap analysis of quality system using FDA laws and regulations.
  • Assists with the development of quality control procedures and SOPs as required.
  • Provided regulatory, quality, and technical expertise to the top management and quality, engineering/R&D, and production departments.
  • Conducted training sessions related to regulatory, compliance, quality, and auditing to top management, and to the quality, engineering/R&D, and production departments.
  • Conducted internal audits of the quality system.
             Initial Importer/ Distributor and Contract Medical Device Manufacturer (Installer and Servicer):  Pan America Hyperbarics, Inc. Richardson, TX
  • Conducted gap analysis of quality system using FDA laws and regulations.
  • Assisted with the development of quality control procedures and SOPs as required.
  • Provided regulatory, quality, and technical expertise to the top management and quality, and installation/ servicing departments.
  • Conducted training sessions related to regulatory, compliance, quality, and auditing to top management, and to the quality and installation/ servicing departments.
  • Conducted internal audits of the quality system.
        Pharmaceutical, Biologic, and Medical Device Specification Developer: Healthpoint, Ltd., Fort Worth, TX
  • Conducted gap analysis of quality system written procedures using FDA and EU laws, standards, and regulations.
 Contract Medical Device Quality Expert, Orchid Design, Shelton, CT
  • Provided technical consulting to corporate, legal and government clients.
  • Provided professional consulting as a FDA Medical Device Quality Systems Consultant.
            Medical Device Client: Mini-Lap Technologies, Inc. Dobbs Ferry, NY
  • Conducted gap analysis of quality system written procedures using FDA and EU laws, standards, and regulations.
 Contract Medical Device Quality Expert,Gerson Lehrman Group, New York, NY
  • Provided technical consulting to corporate, legal and government clients.
  • Provided professional consulting as a FDA Medical Device Quality Systems Consultant.
            Medical Device Client: Miura Global Management, LLC, New York, NY
  • Analyzed business, legal, quality, sterilization and non-conformance data associated with orthopedic implant MDR claims made by another orthopedic implant competitor.
 Contract Medical Device Quality Expert/ Quality Consultant, Engineering Resource Group, Morris Plains, NJ
  • Provides various quality compliance consulting and contracting to corporate, clients.
Contract Medical Device Manufacturer: Medin, Corp, Passaic, NJ
  • Conducted gap analysis of quality system using FDA and EU laws, standards, and regulations.
  • Assisted with the development of quality control procedures and SOPs as required.
  • Ensured product development follows appropriate design control requirements.
  • Provided regulatory, quality, and technical expertise to the engineering, quality, and production departments.
  • Conducted training sessions related to regulatory, compliance, quality, and auditing for top management, and to the engineering, quality, and production departments.
  • Conducted internal audits of the quality system.
  • Developed various regulatory, quality and compliance logs and spreadsheets.
  • Assisted the quality engineer in various quality compliance activities, as needed.
Contract Medical Device Consultant/ Regulatory Specialist, Aerotek Scientific, LLC, Piscataway, NJ
  • Provides various quality compliance consulting and contracting to corporate, clients.
Dental Medical Device/ Pharmaceutical Manufacturer: Sultan Healthcare, Englewood/ Hackensack, NJ     
  • Conducted mock/internal/external FDA/ISO/MDD QSR audits of domestic manufacturing facilities within the medical device realm.
  • Provided technical support, and regulations and standards support to the audit team.
  • Performed in-depth process audits and data analyses, as required.
  • Ensured corrective actions are effective in addressing the root cause to help prevent the recurrence of non-conformities.
  • Performed statistical analysis such as process capability, trend analysis and process control
  • Issue, as required, corrective action and preventive action on the processes
  • Completed technical reviews and analyses of nonconformities, corrective actions and preventive actions (CAPA’s), and complaints as required. Prepare CAPA analyses and issue corresponding CAPA’s.
  • Functioned as the back-up to the QA/RA Manager for review and approval purposes
  • Maintained technical files and risk management files for all devices and pharmaceuticals.  Responsible for organizing and scheduling periodic risk management reviews.
  • Responsible for filing product registration applications and handling government interactions pertaining to the regulation process for registering products in the EU, Japan, Australia and Canada, when requested.
  • Interfaced with customers, regulatory bodies (FDA, TUV, Health Canada) as required.
  • Reviewed, analyzed, and communicated the effectiveness of Corrective and Preventive actions.
  • Reviewed and provided QA technical support of ECN’s.
  • Reviewed label content for regulatory requirements. 
  • Reviewed and approved manufacturing instructions, product and packaging specifications and provide technical assistance.
  • Promoted and supported continuous improvement initiatives.
  • Assured compliance with FDA Quality System Regulations (QSR), Good Manufacturing Practices (GMP), and ISO regulatory requirements.
 Contract Medical Device Quality Expert, Guideline/ Intota, Minneapolis, MN
  • Provided technical consulting to corporate, legal and government clients.
  • Provided professional consulting as a FDA Medical Device Quality Systems Consultant, Governmental Registration Process Consultant, International Business Consultant, GMP Consultant.
  • Can serve as expert witnesses or litigation consultants offering expert testimony, expert advice, litigation support, forensic services, and related expert witness services in litigation areas as a FDA Medical Device Quality Systems, Governmental Registration, International Business, and GMP’s.  
  • Served as a resource to Intota Market Research Services for customized marketing research in industries or areas related to FDA Medical Device Quality Systems, Governmental Registration Process, International Business, and GMP.  
            Law Office (Confidential), Scherrillville, IN           
  • Analyzed, investigated, and reviewed associated documentation, labeling, and potential non-conforming combination pharmaceutical and medical device products. (Case settled due to my expertise.)
            Law Office (Confidential), Redwood, City, CA     
  • Analyzed, investigated, and reviewed depositions and associated MDR/ complaint, et al documentation pertaining to a potential non-conforming surgical medical device product. (Case settled due to my expertise.)
 Regulatory Compliance Auditor, Synthes, USA, West Chester, PA
  • Conducted mock/internal/external FDA QSR audits of domestic and foreign manufacturing facilities of Synthes, including supplier audits, within the medical device realm and advised firm officials on FDA enforcement policies.
  • Completed quality records and/or prepared written procedures (such as pertaining to CAPA validation/verification of effectiveness reports) when requested.
  • Evaluated product designs and manufacturing processes for compliance with regulations.
  • Performed onsite reviews of firm written procedures, processes, and operations and where necessary, recommended corrections for continuous improvement.
  • Established continuous process improvement at various levels at the 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 FDA field and headquarters offices to ensure compliance prior to FDA inspectional visits.
  • Ensured that manufacturers’ employees have proper knowledge of applicable regulations.
  • Developed and implemented business practices improving and reducing operating expenses of company sites (such as aiding in the creation of new device master records).
  • Collaborated with site manufacturing personnel to gather information and explain findings.
  • Conducted training sessions on inspection and investigation techniques and other related topics.
  • Communicated with and maintained customer relations with facility personnel (such as during internal audits of other sites).
Contract Medical Device Quality Consultant, Oxford International, Beverly, MA     
  • Provided technical consulting to corporate clients.
  • Provided professional consulting as a FDA Medical Device Quality Systems Consultant.
            Orthopedic Implant Manufacturer: Abbott Spine, Austin, TX
  • Compiled data necessary to complete 21 CFR 803 MDR baseline reports.
  • Reported to Quality and Regulatory management on bringing the MDR processes and product 510(k)/PMA files into FDA compliance for various class I/III orthopedic implants and accessories.
 International Medical Device Consultant, New World Regulatory Solutions, Inc. Tom’s River, NJ
  • Provided technical consulting to corporate clients.
  • Provided professional consulting as a FDA Medical Device Quality Systems Consultant.
            In-vitro Diagnostic Medical Device Manufacturer- Oxford Innumotec, LLC,
            Oxford, England, UK- August 2007- November 2007      
  • Audited the QSM, Manufacturing, DHF deliverables for consistency and conformance. Review the current Risk management Plan, and all related deliverables.
  • Recommended and setup management controls, design controls, CAPA and process validation protocols and Production Processes as part of the Quality Initiative Program.
  • Audited, reviewed, and critiqued Vendor and Supplier Mfg process SOP’s, data and deliverables for accuracy, completeness, and Quality.
  • Reported to the CEO and VP’s for recommendations on bringing the Manufacturing, Quality, Supply Chain and Design/Manufacturing processes and procedures into FDA compliance for a Class III PMA IDE IVD.
Analyst/Level II Certified International Medical Device Investigator, U.S. Food and Drug Administration, Chicago, IL/ Pittsburgh, PA/ South Bend, IN
  • Conducted routine inspections of domestic and foreign manufacturing facilities and investigated consumer complaints related to FDA-regulated products, primarily within the medical device industry.
  • 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.
  • Advised industry, state, and local officials and consumers on enforcement policies.
  • 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.
  • Fulfilled the duties of the Resident-In-Charge during an extended period of absence.
  • Significant experience in making group presentations.
  • Demonstrated skills in preparing comprehensive and easily understood written communications.
  • Fostered team spirit and open communication on all phases of business.
  • Developed approaches and procedures, which have improved the efficiency of agency operations.
  • Level I/II Certified International Medical Device Investigator.
  • Detroit District Medical Device Co-Leader – Indiana.
  • Detroit District Medical Device Team Leader.

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