Professional Experience and Accomplishments

8/90 to present

Independent Consultant

As an independent consultant I have offered consulting and contracting services in Quality Assurance, Regulatory Affairs Support, and custom programming to the Medical Device Industry.

Results:

• Devised strategy and prepared premarket notifications for software controlled, electromechanical, disposable, brachytherapy, and surgical devices resulting in over forty-nine 510(k) approvals.
• Developed and documented complete Quality Assurance Systems for three companies.
• Designed, coded, validated, and implemented seven software application programs for tracking of product complaints, corrective action, calibration, equipment maintenance, documentation control and receiving inspection.
• Managed GMP compliance activities for three companies under consent decree.
• Performed over 186 supplier surveys including 111 Medical Device Manufacturers.
• Validated aseptic processing procedures and sterilization for human tissues for transplantation
• Developed specifications and donor acceptance criteria for human tissue for transplantation.

  

8/86 to 7/90

Theratek International Incorporated - Manager, Quality Assurance

Theratek was a joint venture initiated by the Cordis Corporation and the Kensey/Nash Corporation in August 1986. Theratek was subsequently sold to Dow Corning Wright on June 29, 1990. Theratek developed the Kensey Catheter, a high-speed rotary atherectomy device. I was responsible for Quality Assurance, Receiving Inspection, Documentation, Drafting, and GMP compliance.

 Results:

• Two FDA inspections resulted in no observations regarding manufacturing, quality, or design.
• Developed all Quality Assurance and Documentation policies, systems, and procedures. Obtained buy-in of product design and manufacturing management resulting in a strong company quality culture.
• Developed computer applications for the integrated control of discrepant material, receiving, vendor status, vendor corrective action, and work order release.
• Specified, purchased, and implemented all inspection and test equipment.
• Developed documentation standards and engineering change control systems.

  

Cordis Corporation - Manager, Quality Assurance Engineering

Cordis is a manufacturer of angiographic catheters and related accessories. I was responsible for failure analysis and corrective action systems, development of quality plans for new products, procurement engineering, and product qualification testing.

Results:

• Recruited, hired, and trained quality engineers to meet increased staff requirements from 4 engineers to 11.
• Coordinated responses and corrective actions to DHSS, FDA, and Internal Audits.
• Planned, documented, and implemented the corrective action system for product complaints.

  

AFA Corporation - Manager, Quality Assurance

AFA is a manufacturer of trigger sprayers that utilizes injection molding and automated assembly equipment. I was responsible for Quality Assurance and Inspection for injection molding, assembly, receiving, and off-shore operations.

Results:

• Developed and implemented a company-wide non-conforming material procedure that provided the ability to track scrap and rework costs.

  

Hyperion Incorporated - Manager, Quality Assurance

Hyperion was a manufacturer of clinical laboratory instrumentation, infusion pumps, and lymphangiographic injectors. I was responsible for all aspects of Quality Assurance, Inspection, and Product Repair.

Results:

• Coordinated responses and corrective actions to DHSS, FDA, and Internal Audits.
• Decreased average turn around time in product repair from 33 to 12 days with no increase in work force.
• Developed, documented, and implemented workmanship standards for electromechanical assembly.
• Developed in-house calibration standards for spectrophotometers and colorimeters.
• Planned, documented, and implemented the corrective action system for product complaints.

  

Saxon was a manufacturer of photocopiers. From 8/78 to 2/82, I was responsible for receiving inspection, competitive equipment evaluation, in-process inspection, and prototype testing for manufactured and OEM products. I was also responsible for qualification and lot testing for consumable supplies such as papers, toners, and photoreceptors. Prior to 8/78, held several progressively more responsible positions with Saxon Industries including branch service manager, quality assurance analyst, and supervisor of quality control.

An ounce of experience is worth a ton of theory. - Benjamin Franklin

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Last modified: March 15, 2008