Pulsion Medical Systems AG, München
- Implementing, operating, and maintaining a QMS according to MDD, FDA GMP, ISO 13485:2003+A1+A2
- Monitoring the application of quality tools and related tests
- Representing the company with customers and authorities
- Managing complaint handling
- Coordinating and executing CAPA actions
- Leading and coordinating the quality assurance department
- Process validation and qualification for production (IQ/OQ/PQ)
- Introducing new in-process controls in manufacturing
- Conducting internal system and external supplier audits