Description
Summary Dedicated professional with 20+ years' experience in Integrated Management Systems, including Quality (ISO 9001), Environmental (ISO 14001), and Health & Safety (OHSAS 18001) with 12+ of those years as Head of Quality Management in different industries. Broad experience in MS-Office, MS-Visio, Project Management (MS-Project) and SAP, cGMP, FDA 21 CFR part 820, ISO 13485, ISO / IATF 16949, IRIS, Supplier Management and all aspects of Process FMEA, Control Plans, IQ/OQ/PQ, Gage R&R, and Statistical Techniques. Solid background in structured procedures for analysis, research, and documentation. Detail oriented organizer and process manager with 30+ years' leadership experience. Self-motivated, articulate and diplomatic communicator and presenter, proactive/creative troubleshooter and problem solver, team player as well as group leader.