Quality Management Team Lead (ad interim)
Medical Devices Class I / IIa / IIb / III, active devices & sterile consumables & Implant Systems;
Responsibility for Documentation Control, Change Management Process, Audit Program
Regulatory Affairs International
Medical Devices Class I / Is / IIa active devices & sterile consumables,
International Registrations (Far and Middle East)
Quality & Regulatory Affairs Manager
Medical Devices Class IIb active devices; (robot-assisted, minimally invasive surgery)
MDR Implementation & Technical Documentation, Gap Analysis (MDD – MDR), General Safety and Performance Requirements, Compliance with IEC 60601-x, IEC 62304, IEC 62366,
International Registrations (CE - US), Risk Management (ISO 14971), supplier management, Quality Assurance Agreements;
Lead Auditor (ISO 13485, ISO 9001)
Quality Consultant, Medical
Devices
Regulatory Affairs Manager Medizintechnik
Interim Management, P-FMEA, supplier approval & audit (ISO 9001, ISO 13485), NCR/Complaints, CAPA-Management, CE & FDA 510(k), notified body change, Documentation transfer, label transition, supply chain, supplier management, Lead auditor
FMEA training concept
Qualification task force, Process & Value chain “device control & power unit”, Certification according to ISO 9001 and ISO/TS16949, Failure Mode and Effects Analysis
Process consultation und modelling according to VDA 6.3
Redesigning Product Development, harmonisation over all process models, training Japanese, American and German employees
Patent DE 10 2012 108 807 A1, Health Care