Quality Systems Engineer
Up to 50% Hybrid
Near Munich
Our client, a global pioneer in the field of sports medicine and orthopaedics is currently seeking an experienced Quality Systems Engineer to support their Quality Assurance & Regulatory Affairs department with the topics concerning quality issues and medical product safety.
Your responsibilities:
- Continuous improvement of the QMS, to include implementation of all relevant RA requirements.
- Ensuring its compliance with ISO 13485 as well as MDSAP.
- Maintenance of ISO 9001 certificates, as well as ensuring QM system accordance with ISO 13485.
- Ongoing support in improvement and implementation of new and existing processes.
- Involvement in the introduction of QM systems to other subsidiaries within Europe.
Your Experience:
- Successful completion of degree in medical technology, electrical engineering or similar.
- Extensive experience with current medical device regulations in Europe, but also FDA & MDSAP.
- Very good technical & analytical “know-how”.
- Great communication & initiative skills.
- Fluency in both English & German languages (to include written and spoken)