Michael L. Wolfe is a seasoned professional in quality engineering and remediation within the medical device industry, boasting extensive experience across various esteemed organizations. Notable roles include serving as a DHF/Technical File Remediation Consultant at Teleflex Medical, leading CAPA/SCAR investigations as a Sr. Quality Engineer I Team Lead at Zimmer Holdings, and currently contributing as a Quality Engineering Sr. Specialist Remediation at Zimmer Biomet. Michael has also demonstrated expertise in creating quality management systems, achieving ISO 13485 certification at Precimed, and has played a significant role in design control remediation and validation processes at multiple companies, including Pfizer and Boston Scientific. Michael holds a Bachelor of Science in Mechanical Engineering with a focus on Aerospace Instrumentation.
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