Medical Device Quality Compliance Consultant Resume

Title
Medical Device Quality Compliance Consultant

Primary Skills
medical device auditing

Location
US-MA-Boston (will consider relocating)

Posted
Apr-18-09


OBJECTIVE
To transition more than 20 years of professional experience in a government, consulting, and industry environment, into a new position utilizing my analytical, communication and creative skills in the areas of domestic and international medical device consulting, compliance, and regulatory, including contract positions and/or permanent positions at consulting and/or medical device companies.

SUMMARY
A Self-starter with good written and oral communications skills and over 20 years of professional experience as a level II certified international medical device investigator in the US government or as a contract consultant and regulatory compliance auditor 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
Medical Device Compliance professional with more then 20 years of progressive experience, including experience in metallurgical engineering. Extensive knowledge in project management, Failure Modes & Effects Analysis, sociology, earth science and media productions. A diverse background in consulting, auditing, manufacturing, and medical device operations, with experience in the medical device industry.

SKILLS
• Audit, review, and critique most lean related manufacturing technologies.
• 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 related protocols and documentation.
• Audit, review and critique all 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.
• Train and Qualify QA, Mfg, Test and Admin personnel related to the manufacturing and test processes.
• Work with ISO/EN/CE, FDA, 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 ISO/ EN 14385/ 9001-9002 certification processes.
• Audit, review and critique validation SOPs and policies according to cGMPs for aseptic process validation, sterilization validation (steam, gamma, EtO, dry heat, etc.).
• Audit, review and critique Large and small vendors for set-up and Transfer of products to vendor sites.
• Audit, review and critique schematics, blueprints and build instructions fort both Electrical and mechanical devices
• Proficient in MAC/PC Applications: MS Windows, MS Office, Word, Excel, PowerPoint, etc.
• Audit, review and critique purchasing control records and operations
• Audit, review and critique Software and Hardware validation.
• 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.).

REGULATORY EXPERTISE
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, GAMP, 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.

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

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 of 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.

EMPLOYMENT HISTORY

March 2009- Present The FDA Group, Worchester, MA
CONTRACT MEDICAL DEVICE QUALITY EXPERT
• Provides technical consulting to corporate, legal and government clients.
• Provides professional consulting as a FDA Medical Device Quality Systems Consultant.

June 2008-February 2009 Aerotek Scientific, LLC., Piscataway, NJ
CONTRACT MEDICAL DEVICE CONSULTANT/ REGULATORY SPECIALIST
Dental Medical Device Manufacturer: Sultan Healthcare, Englewood/Hackensack, NJ
June 2008- February 2009
• Conduct mock/internal/external FDA/ISO/MDD QSR audits of domestic and foreign manufacturing facilities including supplier audits, within the medical device realm.
• Process Audits and Analysis
o Provide technical support, and regulations and standards support to the audit team
o Perform in-depth process audits, as required
o Ensure corrective actions are effective in addressing the root cause to help prevent the recurrence of non-conformities
o Perform statistical analysis such as process capability, trend analysis and process control
o Issue, as required, corrective action and preventive action on the processes
• Complete 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.
• Function as the back-up to the QA/RA Manager for review and approval purposes
• Maintains 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.
• Interface with customers, regulatory bodies (FDA, TUV, OSHA, Health Canada) as required.
• Review, analyze, and communicate the effectiveness of Corrective and Preventive actions.
• Review and provide QA technical support of ECN's.
• Review label content for regulatory requirements
• Review and approve manufacturing instructions, product and packaging specifications and provide technical assistance.
• Promote and support continuous improvement initiatives.
• Assure compliance with FDA Quality System Regulations (QSR), Good Manufacturing Practices (GMP), and ISO regulatory requirements.















July 2008-November 2008 Guideline/ Intota, Bloomington, MN
CONTRACT MEDICAL DEVICE QUALITY EXPERT
• Provides technical consulting to corporate, legal and government clients.
• Provides 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.
• Serves 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 ($100/hr) July 2008
• Analyze, investigate, and review associated documentation, labeling, and potential non-conforming combination pharmaceutical and medical device products.
o Case settled due to my expertise
Law Office (Confidential), Redwood, City, CA ($100/hr) July 2008- November 2008
• Analyze, investigate, and review depositions and associated MDR/ complaint, et al documentation pertaining to a potential non-conforming surgical medical device product.
o Case settled due to my expertise

January 2008 -- April 2008 Synthes, USA, West Chester, PA
REGULATORY COMPLIANCE AUDITOR
• Conducted mock/internal/external FDA QSR audits of domestic and foreign manufacturing facilities of Synthes, including supplier audits, within the medical device realm
• Complete quality records and/or prepare 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
• Advised firm officials on FDA enforcement policies
• 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 site locations)
• Significant experience in making group presentations to firm personnel.

November 2007- December 2007 Oxford International, Beverly, MA
CONTRACT MEDICAL DEVICE QUALITY CONSULTANT
Orthopedic Implant Manufacturer: Abbott Spine, Austin, TX- Nov 2007- Dec 2007
• Compile data necessary to complete 21 CFR 803 MDR baseline reports.
• Report 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.








August 2007- November 2007 New World Regulatory Solutions, Inc. Tom's River, NJ
INTERNATIONAL MEDICAL DEVICE CONSULTANT
In-vitro Diagnostic Medical Device Manufacturer- Oxford Innumotec, LLC,
Oxford, England, UK- August 2007- November 2007
• Audit the QSM, Manufacturing, DHF deliverables for consistency and conformance. Review the current Risk management Plan, and all related deliverables.
• Recommend and setup management controls, design controls, CAPA and process validation protocols and Production Processes as part of the Quality Initiative Program.
• Audit, review, and critique Vendor and Supplier Mfg process SOP's, data and deliverables for accuracy, completeness, and Quality.
• Report 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.

January 1985- February 2006 US Food and Drug Administration, Chicago, IL/ Pittsburgh, PA/ South Bend, IN
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 within the medical device industry
• 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 (Detroit District), FDA HQ international medical device inspection planner (ITOB- International and Technical Operations Branch), and FDA HQ International compliance officer (assisting international companies and other federal agencies about FDA laws, regulations, standards, product labeling, etc.)(IRIS- International Regulatory Issues Staff)
• 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
• Detroit District Medical Device Co-Leader -- Indiana, 1998-2000
• Detroit District Medical Device Team Leader, 1996-1997

January 2006- June 2007 VanGo Media/Starquest TV Productions, Gilbert, AZ (Non-Technical)
BUSINESS AND OPERATIONS MANAGER.
• In charge of all operational, administrative, sales, financial, and business functions of a start-up production company, including managing, training and HR of operational and sales forces.
• Applied strong team building and brainstorming techniques to identify business opportunities
• Prepared business plans and all internal procedures
• Recommended marketing opportunities, developed and forecasted budgets / cash flow
• Created policies and procedures for effective management and business development
• Collaborated with others in the marketing of a television program to potential clients
• Applied cooperative teaming and project budget analyses to determine avoidable costs
• Fostered team spirit and open communication on all phases of business
• Worked with production staff in all activities in the production of a television show
EDUCATION AND TRAINING
2006- present: Doctor of BA, Northcentral University, Concentration in International Business, est. 2010, completion (Online Study- in progress)
1991-1999: MBA - Indiana University, Concentration in International Business
1984-1989: BS - Metallurgical Engineering, University of Notre Dame
1978-1982: BS - Chemistry, University of Notre Dame

TECHNICAL QUALIFICATIONS: MAC/PC Applications, MS Windows, MS Office, Word, Excel, PowerPoint

Additional training includes: 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


Certifications
See above


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