Over 20 years of professional experience in the areas of quality management and regulatory affairs
Profound experience as an auditor in the medical technology industry
Has already been successfully placed several times via K-Recruiting
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Overview
- Availability
- Asap, 5 days/week, on-site & remote
- Qualification
- Diploma Specialist ISO 9000; Diploma Medical Software
- Language Skills
- German (native), English (business fluent)
- Relevant Expertise
- Process-/ Project- & Supply Chain-Management, Design- & Process Validation, Risk-, Complaint-, Deviation-, CAPA-, Change Management, Equipment Qualification, Device Design & -Control, Risk analysis, Root Cause Analysis, Document Management, Quality Control, Product-Packaging, Sterilization and Release, Safety- and Health-Management, Lean Management, Excellence Programs, ISO 9001, 13485, 14001, 31000, 14971, cGMP, MDR, FDA, MedTech
Key-Facts
Extract from previous activities
Aerospace Company, Germany
Interim Manager
Strategy- & product development, supply-chain, and regulatory set-up, related to a medical device re-engineering
Project trouble shooter & customer care in the European aerospace industry, focusing on precision optics systems manufacturing
Project Risk- & Validation-Management
Medical Device Company, Germany
Interim Validation Manager
Validation (FMEA, IQ OQ, PQ) Management
Design- & Process Risk Assessment of complex electrical mechatronics robots for MDR-approval (IEC60601-1), following ISO 14971 standards
BioTech Company, Germany
Interim Manager
Greenfield Project
Design- and Implementation Consultant
Design- and Implementation-Support of Certification, Validation, GMP-Commissioning Strategy for technical infrastructure (clean rooms)
Medical Device Company, Germany
Interim Quality Manager
Quality support for a manufacturer in the IVD test equipment supply chain and dialysis supplies (Class IIa)
Medical Device Company, Germany
SME in the Q-Management/ Q-Engineering
Expert in Q-management and Q-engineering for the production of orthopaedic/arthroplastic implants and tools
Turning, milling, cleaning, surface treatment and sterile packaging
Medical Device Company, Switzerland
Head of Quality Management (Perm)
Head of Quality in the manufacturing of combined medical devices
plastic injection, -printing and micro assembling in clean room
Clean room extension, including the Qualification and Validation management
Responsible for the Quality Assurance and - Control department, including product release as well as for 20 direct- and indirect-reports
Management system-, Document-, Compliance-, CAPA-, Change- and Complaint responsibility according to US- and EU-Medical-Device- & GMP-Regulations