Groningen Area, Netherlands
Director Quality Assurance & Regulatory Affairs
Medical Devices
Education
1992 — 1993
Post HBO, Quality Management
University of Groningen 1971 — 1981
Biology
1968 — 1971
HBO, Analist Microbiology
Heymans Lyceum 1962 — 1968
HBS-B
Experience
IMDS Interventional Medical Solutions December 2009 - Present
Cordis, a Johnson & Johnson company January 2004 - October 2009
Cordis Corporation, a Johnson and Johnson Co. 2001 - October 2009
Johnson & Johnson 2001 - October 2009
Cordis Corporation (Johnson & Johnson) 2001 - October 2009
Cordis Europa NV January 2001 - August 2004
Cordis August 2002 - July 2004
Strukton Systems September 1999 - December 2000
Holec Projects July 1996 - September 1999
Sissing Elektrotechniek April 1993 - August 1996
Skills
Quality Assurance, Minitab, GxP, Six Sigma, GMP, Change Control, FDA, Process Excellence, Quality Control, Sop, 21 CFR Part 11, Lean Manufacturing, DMAIC, Green Belt, Design of Experiments, ISO 13485, Computer System..., Medical Device Directive, Validation, V&V, Manufacturing, SPC, TQM, FDA GMP, Process Engineering, CE marking, GLP, CQA, Regulatory Affairs, FMEA, Quality Auditing, Medical Devices, Black Belt, Quality System, CQE, Iso 9000, ISO 14971, CAPA, Continuous Improvement, Cleaning Validation, Design Control, Supplier Quality, R&D, Sterilization, Aseptic Processing, Process Simulation, ISO, Value Stream Mapping, Quality Management, Root Cause Analysis