pamela goldstein

Pamela Goldstein has over 20 years of experience in the medical device industry developing and managing Quality Systems for compliance with FDA, ISO and Canadian regulations. Pam has a specialty in Design Control - working with engineering to ensure software, electromechanical and single-use medical device compliance. Pam also has extensive experience in auditing, training, product and process validation, and supplier management. Pam has held increasing roles of responsibility in Quality Management and Quality Engineering capacities with companies such as GI Dynamics, Medtronic and C.R. Bard. Pam is a member of the leadership team for the ASQ Biomedical Division New England Discussion Group, and is past Program Chair for the ASQ Biomedical Division. She holds a M.S. in Biomedical Engineering from Worcester Polytechnic Institute and a B.S. in Electrical Engineering from the University of Massachusetts at Amherst. Pam is an ASQ Certified Biomedical Auditor, Manager of Quality/Organizational Excellence and Certified Quality Engineer.