Kenneth F. Kopesky
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Kenneth F. Kopesky serves as one of Pilgrim’s medical device industry experts and provides advice on go-to-market strategies and account penetration. Ken brings to Pilgrim over 35 years of experience in the medical device industry involving Class I, II and III devices, establishing corporate policies and oversight for quality, compliance and quality system initiatives.
Professional Experience:
- Recently retired as Vice President of Corporate Quality and Audit for Medtronic, Inc.
- Co-developer and leader of implementation of multiple ISO quality system standards through HIMA (now AdvaMed), FDLI, FDA and Notified Bodies
- Participant in the Global Harmonization Task Force (GHTF), Vigilance Reporting and Quality Systems Working Groups
- Recognized Quality Systems Experts
- Member of AAMI QM Committee , AAMI QM WG1, US SUB-TC 210 Working Group
- Recipient of the CDHR National Partnership for Reinventing Government Hammer Award
Education:
- Graduate of the College of St. Thomas and Brown College
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