Our Quality Officer is responsible for ensuring that all production activities are in compliance with the required guidelines and laws.
- To maintain the Quality Management System according to ISO 13485, EU-GMP and the EU human tissue directive 2004/23.
- To ensure that all necessary testing is carried out and the associated records are evaluated.
- To review and approve changes and associated documentation.
- To ensure that operations, processes and procedures that affect products quality and/or integrity comply with ISO 13485.
- Responsible for supervising the quality officer(s) and quality trainee(s).
- HBO/WO level of thinking.
- 2 year experience in a quality department or medical device and/or GMP production environment.
- Demonstrated knowledge of medical device manufacturing requirements according to ISO 13485.
- Demonstrated knowledge of pharmaceutical manufacturing requirements according to EU-GMP.
- Demonstrated knowledge of human tissue processing requirements according to EU-directive 2004/23.
- Demonstrated knowledge of different (biological) manufacturing processes and operations.
A young company engaged in the development and production of innovative biological implants derived from human donor material or animal tissue. Due to growth in the organisation we are looking for an experienced quality officer to further expand the organisation.
What we offer:
- Fulltime job in a young enthusiastic team (32 hours negotiable).
- Remuneration: depending experience and education.
- Permanent employment contract.
- Dynamic, challenging and varied position within an international oriented medical company.
- Location: Nijmegen.