Our client is a 20+ years established medical device company who are HQ’d in Berlin and are producing high quality instruments and orthopaedic implants for international distribution in over 30 countries.
Due to growth, they are now searching for a Quality Manager to join the RA/QM function, reporting directly to the Head of RA/QM.
Your responsibilities will include:
- Ensuring compliance with ISO 13485 and 21 CFR 820.
- Overseeing CAPA processes, including documentation and evaluation.
- Managing complaints, including investigations and evaluations.
- Conducting Risk Analysis in accordance with ISO 14971.
- Participation in audits, including internal and supplier.
- Creating and reviewing quality assurance agreements.
- Experience in Quality Management of medical devices and the application of ISO 13485.
- Previous involvement with audit processes.
- Experience with Risk Manager in accordance with ISO 14971 is preferred.
- 30 days’ vacation.
- Flexible working hours.
- Home office flexibility offered.
- Targeted training offered to support your continued development.
Please contact Hollie Barry for further information on this position and/or others in Quality Management: firstname.lastname@example.org