Medical Device Regulatory Consultant Specializing in Control Systems, CMO and Vendor Qualification

Expertise

• Medical device FDA/ ISO regulatory compliance.
• Design control systems, both hardware and software, for medical devices
• Risk analysis, vendor qualifications and documentation related to medical devices.
• Software and process validations.
• Design and manufacturing engineering in flowmeters.
• Contract Manufacturer Organization (CMO) selection and qualification for medical devices.
• Drawing and document control systems, configuration and management.
• Human factors programs.
• Component acceptance procedures/ non conforming product disposition.
• Audits, gap analysis and response to FDA 483 forms and warning letters.

Experience

Independent Consultant, 2008 - Present

• On site in England, assisting a British automated diagnostic system manufacturer to develop a Design Control program and plan for software validation.
• With a large Japanese optical equipment manufacturer, developed a Quality Management System for startup of a medical device division.

Chrysalis Technologies Inc., Richmond, VA , Project Leader, 2002 - 2008

• Developed the Design Control program for this start up medical device manufacturer.
• Wrote 21 SOP's which included ISO and IEC standards.
• Established new product requirements and conducted risk analysis.
• Selected and conducted technical QS audits of 43 contract manufacturing organizations and vendors.
• Conducted validations.

Siemens Process Instrumentation, Hauppauge, New York, Director of Engineering, 2001 - 2002

• Responsible for design and manufacturing engineering for this ultrasonic flowmeter manufacturer.

Controls Corporation of America, Virginia Beach, Virginia, Director of Engineering, 1996 - 2001

• Managed design and manufacturing engineering for this ISO 9001 certified manufacturer of scientific flow control systems.

mdi Consultants, Great Neck, New York, 1995 - 1996

• Associate Consultant in an international medical device consulting firm.
• Conducted software validations, risk analyses and compliance audits.
• Established design control program for a heart laser manufacturer.

National Medical Care, Rockleigh, NJ, Manager Dialysis Equipment Group, 1992 - 1995

• Responsible for design, QA/QC, production and field service of automated kidney dialysis systems.
• Brought a seriously deficient department into compliance during an intensive 2 year FDA investigation.
• Conducted process and software validations systems.

Honors & Publications

Credentials

• Lloyd's of London ISO 9000 Lead Auditor

Publications and Patents

• Four issued patents; three pending

Education

• MBA Finance, Drexel University, Philadelphia, PA.
• B.S. Mechanical Engineering, Polytechnic University of New York