Senior Quality Engineering Consultant
CurrentI have over 30 years of Quality Assurance experience in all aspects of medical device, pharmaceutical, and telecommunications manufacturing. Highlights of my qualifications include: auditing, creation of FMEAs, vendor control, validation, SPC, customer representative, corrective action, qualification testing, leading, supervising and managing groups with the primary responsibilities of ISO-9000 and ISO-13485 system inspection, and training. I have worked as a technical writer in an FDA regulated environment and as a quality consultant and validation specialist in both FDA and EU regulated environments.