Validant since Jul 2010
Quality Engineering Consultant
Ortho Clinical Diagnostics Feb 2004 - Jan 2010
Quality Engineer, Senior Level
Ortho Clinical Diagnostics Jun 1999 - Dec 2003
Manager Production Operations Equipment Manufacturing
Ortho Clinical Diagnostics 1997 - 1999
Manager Operations Engineering
Education:
Rochester Institute of Technology 1982 - 1986
Bachelor of Science Engineering Technology, Electronics
Skills:
Six Sigma Lean Manufacturing Project Management Product Quality Organization Capa Iso 13485 Fda Medical Devices Quality System Design Control Validation Continuous Improvement Quality Control Manufacturing Iso 14971 Process Improvement Change Control Quality Assurance Iso V&V Product Development Root Cause Analysis Gmp Dmaic Supplier Quality Manufacturing Engineering 21 Cfr Part 11 Minitab Complaint Management Manufacturing Operations Hardware Diagnostics Fda Gmp Gage R Quality Management Engineering Management Design of Experiments Black Belt Quality Auditing Spc Sop Computer System Validation Gxp Iso 9000 Calibration Process Simulation R&D Engineering Value Stream Mapping Regulatory Affairs