Michael A. Thomas is a recognized quality consultant and professional in the healthcare industry for over 30 years. He has developed state-of-the-art quality systems to support product design and development, manufacturing, customer support, and supplier management operations in numerous companies including Johnson & Johnson, Coulter Diagnostics, Baxter International, bioMerieux, and the Institute for Transfusion Medicine.
Mr. Thomas has held global responsibilities for domestic and international medical manufacturing facilities and has been instrumental in procuring and maintaining ISO9000, ISO13485, and EU/CE certifications for several medical device companies. He is a well-known international troubleshooter and problem-solver, and has taught over 300 engineers and technicians in root cause analysis techniques.
Mr. Thomas is an authority in Quality Auditing, Process Validation, Product Validation & Verification, CAPA Systems, and Risk Management. He has over 20 years of experience in dealing directly with the FDA as a Quality Director-level and above Management Representative for several organizations.
At the Baxter Healthcare Renal Division, he directed the quality functions required for the successful development and risk management activities of numerous dialysis product introductions, cultivating a close hands-on partnership with product development throughout the Design Control process.
He holds degrees in Chemistry and Psychology from University of Florida. He has attained certification as an ASQ certified Quality Engineer, a Baxter certified Six Sigma Engineer, and certified Quality Professional. He is a member of American Society for Quality (ASQ). He has also been a member of American Association of Blood Banks (AABB), America’s Blood Centers (ABC), and American Association for Medical Instrumentation (AAMI).