Michael LeDee is a Director of QA with extensive experience in global quality management, regulatory compliance, and business operations across the medical device, clinical, IVD, and pharmaceutical industries. They have held notable leadership roles at organizations such as Abbott Diabetes Care, Thermo Fisher Scientific, and Roka Bioscience, where they managed large teams and oversaw quality management systems and inspections. Michael holds a BS in Chemistry from the University of California, Davis, and possesses in-depth knowledge of various quality standards and regulatory compliance processes. Currently, they serve as the Director of QA at Karius while continuing to lend their expertise as a Senior Quality Consultant.
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