Position:
Sr. Quality Engineer at Insulet Corporation
Work:
Insulet Corporation
- Bedford, MA since Aug 2011
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Sr. Quality Engineer
Disetronic Sterile Products
2005 - 2010
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Director of Quality & Regulatory Compliance
McCue Corporation
2003 - 2005
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Quality Manager
UroMed
1993 - 1997
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R&D Technician
Education:
University of New Hampshire
Skills:
ISO 13485, ISO, Medical Devices, CAPA, FDA, Minitab, Quality System, ISO 14971, Process Engineering, Design Control, FMEA, Quality Control, Manufacturing, Manufacturing Engineering, GMP, Regulatory Affairs, Root Cause Analysis, Iso 9000, Continuous Improvement, Product Development, FDA GMP, Quality Auditing, Quality Assurance, Quality Management, Lean Manufacturing, V&V, Validation, Design for Manufacturing, 21 CFR, TQM, Sterilization, Kaizen, 21 CFR Part 11, Injection Molding, 5S, Supplier Quality, Design of Experiments, Calibration, Sop, DMAIC, SPC, Six Sigma, Value Stream Mapping, Biomedical Engineering