Certified Quality Auditor: FDA-QSR Systems Consultant, Software Quality Analyst and Course Development and Assessment

Technical Consultant #1679


Expertise

  • Auditing for ISO 13485, FDA QSR, ISO 9001, MDD and IVD, CE mark.
  • Specialist on FDA regulated industries and software validation requirments.
  • Process validation, software validation, Part 11, GMP development, ISO 13485 development.
  • FDA response and remedial actions, quality systems creation, quality systems improvement.
  • Creation of technical course and leading training groups on FDA-QSR and Software Quality, including training effectiveness assessments.
  • FDA quality documentation, risk management, specification development and sampling plan analysis and rationale.

Experience

Undisclosed Company, Senior FDA Quality Systems Consultant, 1995 - Present

  • Multiple project assignments in FDA regulated industries in the areas of software validation, quality systems development, compliance, validation and ISO certification.
  • Senior American Society for Quality (ASQ) certified auditor.
  • ASQ certified software engineer.

Undisclosed Company, Consultant, 2006 - Present

  • FDA-ISO consultant to create quality system and documentation and manage FDA audit response.
  • Prepare documentation for CE marking under annex VI, subsequently under annex II.
  • Manage ISO 13485 and Canadian license activities with Emergo.
  • Provide example of audit response format to BSI for use as an example to other registrants.

Separation Technology Inc., Altamonte Springs, FL, Consultant and Acting Quality Director, 1999 - Present

  • Revise and improve quality systems documentation.
  • Prepare firm for FDA inspections, manage and direct responses and corrections.
  • Write validation protocols for customers', prepare validation reports based upon data.
  • Create data studies in support of CBER-CDRH 510-k.

Garland Manufacturing Company, Saco, ME, ISO 9001 Consultant, 1993 - Present

  • Analyzing firms processes, employee training, selected NQA as certification authority, create quality systems documentation, perform annual surveillance audit.

Candela Laser, Wayland, MA, International Regulatory-Quality Systems Analyst, 2008

  • Analyzed firm's submissions in 15 countries, created gap analysis for each situation, compiled spreadsheet of regulatory requirements and registration methods in each country.

Sunquest, Tucson, AZ, Quality Systems Consultant- Design Control Auditor, 2008

  • Led quality group project to create a process based quality system with metrics and continual feedback.
  • Planned and carried out an audit of the design control practices using ISO 13485 and general software quality requirements.
  • Led quality group project to create a process based quality system with metrics and continual feedback.

Respironics, Murrysville, PA, Part 11 and electronic DHR Consultant, 2007

  • Led quality group project to identify records subject to Part 11 and determine methods to use SAP in creating electronic batch records.

GAMBRO, Medolla, Italy, Part 11 Record Identification Consultant, 2006

  • Worked with engineering and quality personnel to identify all records and software used.
  • Created an interview and analysis method to quantify the number of records needing Part 11 and software needing validation.

Honors & Publications

Credentials

  • Graduate Certificate, Biomedical Engineering, North Eastern University
  • Certified Quality Auditor
  • Certified Biomedical Auditor
  • Certified Software Quality Engineer
  • ASQ Fellow, ASQ Board of Directors Testimonial Award
  • Volunteer of the Year Award- ASQ Biomedical Division
  • Shirl Furger Service-Leadership Award- ASQ Food Drug & Cosmetic Division
  • RAB Quality Systems Auditor
  • Massachusetts Quality Award - Board Member and acting Chair
  • MIT Alumni Association Volunteer Honor Roll of Service

Academic and Professional Affiliations

  • ASQ American Society for Quality
  • AAMI American National Standards Institute
  • Mass Excellence (Massachusetts Quality Council)
  • CLSI (formerly NCCLS) working groups on Quality Systems

Publications and Patents

  • Putting Closure on Complaints and Audits using CAPA, J of GXP Compliance
  • Non-conformance-Defining the Problem, ASQ-Biomedical Seminar
  • Annual Product Review as Preventive Action
  • ASQ Biomedical Auditor Exam Overview, ASQ-Biomedical Seminar

Education

  • B.S. Chemical Engineering, MIT, Cambridge, MA
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