Enschede Area, Netherlands
Sr. QMS consultant at Depuy Synthes
Medical Devices
Education
Universiteit Twente
MSc, Drs, Ir
Experience
Emergo Group 2007 - Present
mediQwise 2005 - Present
DePuy Synthes (Companies of Johnson & Johnson) January 2014 - March 2015
Synthes July 2013 - December 2013
Volcano Europe October 2012 - June 2013
Pfizer May 2012 - October 2012
Stryker December 2010 - June 2011
Zimmer March 2010 - October 2010
Abbott Vascular Devices 2009 - 2010
Zimmer March 2008 - April 2009
Skills
Regulatory Affairs, Risk Assessment and..., Design Control, Clinical Trials, Vigilance and MedWatch, Regulatory Filings, Software Validation, FMEA, ISO 14971, Computer System..., ISO 13485, Cleaning Validation, Product Validation, CAPA, PMA, cGMP, Complaint Handling, Requirements..., Post Market..., Process Validation, Biomedical..., Quality Assurance, Auditing, 510 K, Process Auditing, Quality Systems, Change Control, Corrosion, Supplier Audits, QSR, Biomedical Engineering, 21 CFR Part 11, Compliance Audits, CE marking, 503(g), MDD / AIMD / IVD..., ISO standards, Data Validation, Medical Devices, Regulatory Reporting, Diagnostics, Validation, Regulatory Submissions