Manufacturing • Medical Devices • Quality System • Fda • Quality Assurance • Lean Manufacturing • Validation • Continuous Improvement • Iso • V&V • Gmp • Fmea • Spc • Root Cause Analysis • Cross Functional Team Leadership • Product Development • Process Improvement • Quality Management • Capa • U.s. Food and Drug Administration • R&D • Product Launch • Mapping of Repetitive Work and Ergonomic... • Value Stream Mapping • Iso 13485 • Design Control • Design of Experiments
Design Ready Controls
Quality Specialist
Cpc Dover Nov 2016 - Jun 2017
Zone Lead
Coloplast Nov 2005 - Oct 2014
Surgical Mfg Molding and Assembly Technical Lead
Dahlberg Elec Miricle Ear Memsi Jun 1995 - Apr 2003
Lead Trainer and Qa
Starkey Hearing Technologies Jan 1979 - Jan 1990
Service Department Supervisor
Skills:
Manufacturing Medical Devices Quality System Fda Quality Assurance Lean Manufacturing Validation Continuous Improvement Iso V&V Gmp Fmea Spc Root Cause Analysis Cross Functional Team Leadership Product Development Process Improvement Quality Management Capa U.s. Food and Drug Administration R&D Product Launch Mapping of Repetitive Work and Ergonomic Issues Value Stream Mapping Iso 13485 Design Control Design of Experiments
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