My client, an international contract manufacturer for Medical Device and Diagnostics, are looking for an experienced manager to join the team as Head of Operational Quality Assurance, reporting into the Head of Quality and Director of Global Quality - Medical.
You and your team of QA specialists and quality inspectors will ensure that the quality specifications of medical devices are met and continually optimise processes and methods to increase the efficiency and effectiveness.
You will also work closely with the other department leads to ensure quality processes are aligned across the business.
Responsibilities:
- Coordination and organisation of incoming goods inspection processes.
- Maintaining clean-room qualification, including carrying out regular monitoring.
- Recording and processing deviations, changes and CAPAs
- Coordination and organisation of the batch release and conducting a documented batch record review
- Timely release or blocking of incoming goods, semi-finished goods and finished goods.
- Timely communication of deviations according to their importance.
- Personnel management of 7 employees.
Requirements:
- Technical qualification/university degree and experience in a relevant field e.g. medical engineering
- Good knowledge of ISO 13485 / 14644 / 14971
- IT tools (e.g. Office, SAP, QM tools)
- Excellent German and English language skills
- Previous management / leadership experience
