George Zack

Experience

• 

  United States Air Force

  Feb 1988 - Mar 1990

  Navigational Systems Airman
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  Daily Camera

  Apr 1998 - Jun 1999

  Network Analyst
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  Mckesson

  Jan 2007 - Apr 2016

  2010 – 2016: Defined and started initial medical device audit program and then led staff in the execution of internal medical device regulatory and quality audits against US, EU and Canadian regulations and standards at domestic and international locations. Exceeded expected scheduled audit expectations in each performance year. Drove the growth of program from software medical devices (MTS) into Pharma distribution and repackaging centers (MDS). Sites participating in audit program that were inspected by FDA or other regulatory bodies had no necessary official action indicated. Also participated in CMMI process assessments to drive organization improvements and further assure the quality of our products for non medical device products. Show less

  • Director of Development Process Standards

    May 2010 - Apr 2016

  • Senior Project Manager

    Jan 2007 - May 2010
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  Two Harbors Consulting

  Apr 2016 - now

  Principal and Co-Founder

  Every business has a unique set of circumstances and needs. Two Harbors Consulting, through our combined expertise, delivers process and performance improvements tailored to these needs. Our solutions are based on industry frameworks but applied with flexibility and a genuine desire to facilitate success.

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  Meta

  May 2024 - now

  Quality Compliance