Owner, Roberts Consulting & Engineering and Medical Devices Consultant
Mark Roberts is the head of Roberts Consulting and Engineering (RCE), a consulting firm specializing in quality system and sterility assurance compliance. He was previously the Manager for the Western US for TÜV SÜD Product Service. He is an accredited lead auditor and notified body auditor. He still performs audits and product/sterilization file reviews for notified bodies on a contract basis. He has 30 years of experience in the medical device industry.
Prior to joining TÜV he was with Becton Dickinson in their corporate offices as manager of sterility assurance. He also held various positions in RA/QA, sterility and engineering for Baxter Healthcare. He is a member of AAMI and ASQC Biomedical. Publications include portions of the ASQC Biomedical Quality Auditor Handbook. He has also been an expert witness on quality systems and sterility for the FDA.
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