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Goal focused Quality Leader in medical devices and pharmaceuticals
Began career with 10 years with the FDA in the Detroit District office and at the Kalamazoo, MI and Grand Rapids Resident Posts. Conducted inspections at pharmaceutical and medical device companies, conducted investigations and testified in court. I Left for a start-up medical device contract manufacturer where I developed the quality system and initiated 510(k) submissions. I also identified and resolved problems resulting in savings over $250K. I I transferred my skills to the implantable pacemaker industry where I was involved in setting up audit programs, ISO 13485 quality systems, managing complaints and MDR reporting, coordinating regulatory requirements for moving new manufacturing facility, and coordinating and managing recall efforts. I have worked with several companies that encountered serious regulatory problems and have been successful in resolving the crises. As a quality consultant, I have developed and implemented numerous quality systems to meet FDA and ISO requirements. I have developed and implemented comprehensive audit programs and conducted numerous audits and identified corrective and preventive actions. I am a Lead Auditor to ISO 13485:2003. I have provided third party certification to FDA for company under consent decree.
Quality Assurance Director
About Me
Industry: |
Healthcare & Medical |
|---|---|
Occupation: |
Quality Assurance Director |
Highlights: |
Developed several quality systems to meet FDA and ISO requirements. Successful in resolving and overcoming regulatory compliance issues (Warning Letters, Consent Decrees) at several companies. Successfully led companies to ISO certification. |
Ideal Companies: |
Small to large medical device or pharmaceutical companies such as Abbott Laboratories, Baxter, CR Bard, Phillips, Medtronic, Boston Scientific, St. Jude Medical, Johnson & Johnson, Bausch and Lomb. |
Education level: |
Bachelor |
Will Relocate: |
Yes |
Location: |
Sun City Center, FL |
Major Responsibilities
Work Experiences
9/2005 - Present
(private)Self-Employed
- Develop and implement FDA compliant Quality Systems, update GMP/ISO training
1/2005 - 8/2005
Accutron, Inc
Director / VP
- Implemented Quality System, internal audit program. Organized and managed electronic documentation system.
10/2003 - 12/2004
Corium International
Manager
- Conduct Internal and supplier audits; Interface with clients and regulatory agencies during audits and inspections. Conduct periodic GMP/ISO training sessions
1/2002 - 9/2003
Emergo Group Consultants
Contractor / Freelance
- Develop and implement quality systems to meet FDA and ISO requirements, prepare 510(k) submissions and Technical Files for clients
7/1999 - 12/2002
Witt Biomedical Corporation
Director / VP
- Developed and implemented comprehensive Quality System to meet FDA/ISO requirements; Interface with FDA during inspections and ISO representatives during audits. Successfully resolved FDA warning letter issue. Prepared 510(k) submissions and prepared International submissions to Canada, Japan, PRC, Taiwan, Australia, Korea, Malaysia to enable expansion to International markets.
3/1995 - 6/1999
MDI Consultants, Inc
Director / VP
- Started West Coast office for companyDeveloped and implemented quality systems to meet FDA and ISO 9001 requirements. Provided thrid party certification to FDA in response Consent Decree. Prepared over 10 510(k) submissions.
12/1993 - 3/1995
Siemens Pacesetter, Inc
Director / VP
- Implemented internal Audit program, Coordinated efforts to work out from under Consent Decree. Interacted with FDA Investigators during inspections and ISO auditors during audits.
12/1990 - 11/1993
Intermedics, Inc
Manager
- Implement and manage Quality System. Implemented ISO 9001 system (1st pacemaker company certified to ISO). Coordinated regulatory activity to move to new manufacturing facility. Coordinated MDR and Product Vigilance reporting. Implemented and managed recall activity. Coordinated Engineering Change Board.
9/1989 - 12/1990
Coulter Electronics
Manager
- Expanded and Managed Quality audit function. Coordinated complaint investigations (reduced backlog of complaints by 90%)
7/1985 - 11/1989
Cordis Corporation
Individual Contributor
- Conduct internal audits, Interface with FDA during inspections. Responded to FDA findings. Prepared and presented reports to Board of Directors each Quarter.
7/1982 - 6/1985
Meditect, Inc.
Director / VP
- Developed and implemented Quality System. Resolved supplier quality issues resulting in over $100k in savings. Implemented solvent recovery system resulting in over $150K in savings. Prepared and submitted initial 510(k) submissions.
7/1972 - 7/1982
