Experienced and Independent Medico- and Pharmaceutical Consultant with expertise in QC, QA and preparing businesses for successful FDA-inspections.Selected Jobs:DePuySynthes (Johnson & Johnson) - placement in Basel, Switzerland. Prepared QMS and documented Design History and Risk Management plans to prepare for DePuy and Synthes merger.DAKO A/S - Denmark. FDA remediation program. The Company passed the FDA Inspection without any observations.Anonymous IVD Company - Denmark. Complaint Handling and Vigilance Area.Anonymous IVD Company - Denmark. Mock audit, gap-analysis and improving SOP/ Instructions and training in the complaint handling to prepare for successful FDA inspection.

Plant Manager for the two Danish factories, CODAN Medical and CODAN Steritex, with special focus on the RA/QA-area.Applying LEAN-principles applied to Group Quality Control together with FMEA , process studies and process validations, and it was used to improve both the In-process QC and incoming- and final inspection process.Increased productivity by 30% the first three years and doubled the bottom line in the same period.Changed the Quality System to comply with ISO 13485 (2003/2009) and the new EC MDD (2007). Prepared the system to also fulfil the US QSR requirement, as 510 k’s was being prepared to enter the US market.

Overall responsibility for the Maersk Medical Group world-wide RA and QA activities as well as for the overall Maersk Medical Group development of QM systems and that all entities had a uniform profile against, Authorities, Customers and Suppliers. Prepared all units for FDA and NB inspections and planned for and carry out RA/QA due diligence in Companies supposed to be acquired by Maersk Medical.Developed Electronic Quality Management system to be used at Group Level12 successful FDA Inspections carried outImplemented Group Quality Management System in new facilities in India and Mexico

Overall P/L responsibility for the Business Unit