
Quality Assurance Medical Devices - Gothenburg
- Göteborg
- Permanent
- Heltid
- Participate and contribute to strategic planning and decision-making related to QMS.
- Identify, define, and implement improvement opportunities within QMS processes
- Review and approve quality procedures in line with ISO, MDSAP, and MDR 2017/745 requirements.
- Lead and drive investigations related to non-conformities (NCs) and Corrective and Preventive Actions (CAPAs).
- Review Change Requests (CR) and Change Order checklists concerning QA.
- Collaborate with cross-functional teams to approve temporary non-conformities.
- Full-time assignment.
- Hybrid setup possible, with at least 60% onsite presence required.
- Start date: ASAP.
- Strong experience in Quality Assurance, Test, and Validation within medical devices.
- Proven knowledge of applicable regulatory frameworks (ISO, MDSAP, MDR 2017/745).
- Ability to collaborate effectively across different functions and drive QA initiatives.
- 📄 Secure & Transparent Employment