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

Technical Consultant #1588


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
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