Randy Koester’s Email & Phone

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Randy Koester

Sr Director Global Quality Assurance @ Waters Corporation

Randy Koester Contact Details

Greater Boston Area
Sr Director Global Quality Assurance @ Waters Corporation
Device & Combination Product QMS Remediation Consultant @ Shire
Vice President Quality @ GI Dynamics

Results-oriented professional with over 15 years of proven experience in a diverse range of regulated Class 1, 2 and 3 medical device manufacturing industries. Proficient with FDA implementation of regulatory compliance strategies, Quality System Requirements (ISO13485, ISO14971 and FDA 21 CFR parts 820, 210, 211, & 4) leading to demonstrated success in multiple FDA inspections with zero 

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