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