Senior Quality Engineer, Medical Devices & IVD (FDA/IVDR)

A pioneering healthcare technology company is seeking a Lead Quality Engineer in New York. This role involves ensuring the quality assurance of medical devices and laboratory developed tests, overseeing cross-functional team compliance with FDA and EU regulations, and managing post-market surveillance activities. The ideal candidate will have over 5 years of experience in the medical device industry, a BS degree in Engineering, and strong knowledge of regulatory requirements, making a significant impact in advancing healthcare solutions.

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