ASQ Certified Quality Engineer

More than seventeen years experience in quality assurance management in medical devices, electromechanical instrumentation, and clinical laboratory instrumentation.

Extensive hands-on experience in the development of policies, systems, and procedures for medical device company startups.

Highly experienced in the conduct of GMP audits of medical device manufacturers, over 111 audit GMP audits performed.

Highly experienced in the conduct of quality audits of suppliers to the medical device industry, over seventy-five audits performed.

Extensive experience in injection molding, extrusion, machining, electrochemical etching, laser welding, assembly, and packaging material conversion.

Extensive experience in the validation of gamma and ethylene oxide sterilization processes.

Co-inventor of a bone marrow biopsy needle, patent no. 5,368,046.

Highly experienced with IBM-compatible computers; have coded numerous Visual Basic, rBase, and PAL database applications used by medical device and pharmaceutical companies.

Hands-on experience in precision dimensional measurement.

Researched, wrote, submitted, and attained approval for over forty-three 510(k) premarket notifications.

Experienced in clean room design, construction, and operation.

Hands-on experience dealing with the FDA during inspections, responses to FDA Form 483s, and other compliance issues.

Completely familiar with medical device GMP and other regulatory requirements.

Extensive experience in engineering documentation management and engineering change control in a GMP environment.