Description
Summary of Career Milestones: * BS degree in Industrial Technology. Final semester of a combined Masters Program * 25 years in various manufacturing environments including electro-mechanical, medical devices and Aerospace/Defense * Lean Six Sigma Master Black Belt Certified (LSSMBB) (Global Cert - Germany and Villanova University) * Multiple Quality related certifications from ASQ, ASNT, RAB, IRCA, SME. * Certified International Instructor in TQM and ISO (Global Cert - Germany) * Significant international experience, primarily in Asia, Europe, India, Malaysia and Mexico. * Expertise with FDA/GMP, ISO 13485:2003/MDD, the Canadian Medical Devices Regulations (CMDR), JPAL and other international requirements. * Successful implementation of ISO 9000:2008, ISO 13485, AS 9100 and 21 CFR Part 820. * Served 4 consecutive terms as a Director on the NASA/Contractor Board * Supports the preparation of 510k, PMA's or IDE's for FDA on new or revised products. * Received Manager of the Year award at Leach, and a Silver Snoopy Award from Martin Marietta * Extensive experience with Medical Device, Aerospace and Commercial Manufacturers ISO 9000 International Quality Systems Lead Auditor IRCA #A001631 2 - 00
