Quality Assurance Manager for Central Europe - Germany
- Provides leadership and strategic direction for the Quality Management System in compliance with European and FDA requirements for in-vitro diagnostic products.
- Implementation and maintenance of local Quality Management System in accordance with the Global RA/QA strategy and in compliance with European and FDA requirements.
- This includes among other things systems and processes for:
- Quality Improvement
- Document Control
- Nonconforming Products/OOS
- Change Control
- Complaint Handling
- Design Control
- Risk Management
- Management Review
- Batch Record Review and Batch Release
- Offer quality related training for Munich site
- Execution of internal audits as lead auditor for the site
- Quality contact for authorities and notified bodies
- Management of notified body or authority audits
- Bachelor’s or Master Degree in Science
- A minimum of eight 8 years, with direct responsibility for Quality Management Systems and related compliance to current Quality Systems Regulation and other relevant standards (e. g. ISO 9001).
- Knowledge of QMS requirements applying to in vitro diagnostic products
- Quality Engineering and /or Six Sigma Black Belt certification preferred.