Sealand Region, Denmark
Principal Consultant at NNIT. Lead Auditor. LION
Medical Devices
Education
The Danish Meat Trade College 1998 — 2001
Levnedsmiddeltekniker/Food Stuff Technician, Food
Courses
Experience
NNIT September 2015 - Present
AL Engineering A/S November 2012 - August 2015
Elsmar Cove November 2006 - November 2014
GxP Systems August 2012 - February 2013
Widex A/S August 2010 - August 2012
Ambu A/S April 2007 - July 2010
Angiotech, Denmark April 2006 - March 2007
Unomedical March 2001 - August 2004
Skills
Quality System, Medical Devices, Software Implementation, CAPA, Validation, Complaint Management, Cross-functional Team..., GMP, Root Cause Analysis, Complaint Handling, Testing, ISO, QSR, Quality Assurance, Software Validation, Deviations, SPC, Manufacturing, Quality Control, ISO 14971, Iso 9000, 21 CFR, Six Sigma, Validations, Quality Systems, Process Improvement, Internal Audit, Continuous Improvement, Change Control, 21 CFR Part 11, ISO 13485, R&D, External Audit, V&V, FDA, FMEA, Databases, Sop, Database Design, Regulatory Requirements, Process Validation, Regulatory Affairs, GLP, Lean Manufacturing, Auditing, Design Control, Quality Management, Database Development, Regulatory Submissions, Quality Auditing