Burg Pharma Bulgaria Ltd. is looking for a motivated Quality Manager Medical Devices to join their team.
Tasks
- Maintenance of quality management systems (e.g. creating / updating SOPs) for medical devices (Class I to III)
- Working for Burg Pharma GmbH – following the laws applying in Germany and Austria
- Working indirectly for Burg Pharma AG – following the laws applying in Switzerland
- Approval of products (labels, IFU, suppliers, etc.) under MDD / MDR
- Organization of audits and documents (e.g. CE, DoC, ISO)
- Working directly with QMB / PRRC
- Link to pharmaceutical Quality team for overlapping topics (e.g. warehousing and logistics)
- First point of contact for suppliers / partners on Quality topics for medical devices
Qualifications / skills required
- Experience in Quality Management for Medical Devices (MDD & MDR)
- Experience with wholesale of medical devices
- A solution-oriented mindset
- Very good written and spoken English skills
- German language skills would be beneficial
- Independent, self-reliant, structured, and results-oriented working style
- Scientific background (e.g. degree in Natural Sciences, Pharmacy or Engineering)
Permanent full-time contract from Burg Pharma Bulgaria Ltd
Application link: https://www.jobs.bg/job/8078990
