Michael O’Hara joined Miach Orthopaedics as vice president of quality assurance in 2019. For nearly seven years, he served as senior director of quality assurance for TransMedics, Inc., where he led premarket approval (PMA) submissions for two products and oversaw U.S. Food and Drug Administration manufacturing inspections.
O’Hara has more than 23 years of experience in compliance, product quality, quality systems and customer satisfaction. Prior to joining TransMedics, he served as director of global quality assurance for ABIOMED, where he was responsible for the strategic planning and organizational development of the global quality team and led successful, unannounced FDA and PMDA inspections. He has also served in quality leadership roles at Medtronic and Baxter.
O’Hara is a certified quality engineer, a certified lead auditor, and a certified Lean (Six) Sigma Green Belt. He holds a master of science in bioengineering from the University of Illinois at Chicago and a bachelor of science in biomedical engineering from Marquette University in Milwaukee.