Medical Device Expert for Quality Assurance and Regulatory Compliance

Technical Consultant #1642


Expertise

  • Over twenty-five years of experience in the engineering, development, manufacturing, quality assurance and servicing of medical devices.
  • Establishing and monitoring of drug and device quality systems, including equipment qualification and process validation.
  • Response to FDA warning letters.
  • cGMP and QSR compliance; CAPA - Corrective and Preventive Action.
  • Equipment qualification and validation.
  • Design verification and validation.

Experience

Independent Consultant, 2008 - Present

  • Developed rationale and performed equipment qualifications and process validation for a new, fully automated manufacturing facility producing hemodialysis filters.

Undisclosed Consulting Firm, Senior Quality Systems Associate, 2002 - 2008

  • Worked with a device manufacturer under a FDA warning letter to assess the adequacy of the Design History Files and recommend remediation activities for those determined to be inadequate.
  • Worked with a European device manufacturer under an import restriction to establish an acceptable Corrective And Preventive Action (CAPA) process which included participation in the remediation of previous inadequate CAPAs.

Senior Quality Systems Associate, 2004 - 2005

  • Worked with a device manufacturer to develop test method protocols for design verification and validation of products and processes.
  • Assess the adequacy of the design history files for a family of combination device and drug products.
  • Assisted in the remediation of unresolved Corrective and Preventive Action (CAPA) files.

Quality System Advisor, 2000 - 2001

  • Worked with a major in-vitro device manufacturer under a consent decree to establish and monitor the performance of product and process risk analysis methods and evaluate the resulting remediation activities.

Practical Compliance, Brevard NC, Compliance Consultant, 2006 - 2008

  • Assess the adequacy and implementation of their CAPA and complaint handling processes with an emphasis on MDR compliance.
  • Develop the validation protocol for a software tool used as a production aid.

QRC Associates, Annapolis, MD, Quality System Consultant, 2002 - 2003

  • Worked with a pharmaceutical manufacturer under a warning letter to establish a quality system compliant with the requirements included in the "Compliance Program Guidance Manual for FDA Staff: Drug Manufacturing Inspections."
  • Performed an in-depth audit of the client's material control, complaint and corrective action systems and later assisting in the correction of identified deficiencies.

Creative Technology Systems, Consultant, Newark, DE, 1999 - 2000

  • Develop and implement an ISO 9000 and QSR (Quality System Regulation) compliant quality system for a contract manufacturer of medical devices.
  • Design and manufacture the electronics and associated software for XTRX, a device for the pre-purification of High Pressure Liquid Chromatography (HPLC) samples.

Sterling Diagnostic Imaging, Glasgow, DE, Quality Engineer, 1996 - 1999

  • Developed and maintained an FDA registered and ISO 13485 certified quality system.
  • Established and implemented processes for the CE marking of medical devices that resulted in opening the European union market for 6 major products.
  • Managed and launched the Quality Module of the SAP software system. SAP, a state of the art Enterprise Resource Planning system, replaced a non-Y2K compliant Manufacturing Resource Planning (MRP) system.

E. I. DuPont Medical Products, Wilmington, DE, Quality Specialist, 1984 - 1996

  • Consolidated two separate ISO 9002 registered manufacturing organizations into one streamlined organization with one registration.
  • Developed and implemented processes that resulted in the upgrading of the above quality system to ISO 9001.
  • Monitored and directed the quality activities of 5 manufacturing and warehouse sites. This included: Managing the internal audit process; auditing to ensure that the sites complied with the QSR (Quality System Regulation); and managing corrective and preventive actions pertaining to in-vitro devices.
  • Assisted, as a member of HIMA (Health Industries Manufacturing Association) Software Task Force, in proposing guidelines to be established by the FDA for the validation of software included in medical devices.

Honors & Publications

Academic and Professional Affiliations

  • American Society of Quality (ASQ) - Retired

Credentials

  • ASQ Certified Quality Engineer
  • Certified Lead Assessor %u2013 ISO 9001

Publications

  • Root Cause Analysis %u2013 Presentations in Europe and the United States

Education

  • Electronic Engineering Technology, Tennessee Institute of Electronics, Knoxville, TN
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