Quality Manager in the field of medical devices
Based in Freiburg
Are you driven to make healthcare better by ensuring due diligence from start to finish!
Our candidate is an expert in regulatory matters and quality management and offers services in all associated fields, guaranteeing that their clients may access the market at a reasonable cost and reimbursement rate. In other words, they work to maximise every facet of development.
- Support and maintenance of the internal quality and information security system according to EN ISO 13485 and ISO/IEC 27001.
- Ensuring compliance with EU requirements according to MDR (EU) 2017/745 and IVDR 2017/746 respectively.
- Interactive collaboration with in-house experts covering all topics related to 13485 as well as 27001 and CE marking of medical devices/IVDs.
- Supplier qualification and auditing.
- Contract management / quality assurance agreements.
- Development of creative solutions to meet customer needs in conjunction with QM as well as regulatory requirements.
- Close cooperation with international customers as well as with Notified Bodies and Competent authorities.
- Completed training or studies in the fields of natural sciences, medical technology, engineering or comparable educational background
- Relevant knowledge and practical experience in the implementation and maintenance of
- management systems according to EN ISO 13485 / ISO/IEC 27001
- Experience in CE marking of medical devices / IVDs
- Experience in the medical device industry, preferably in positions in the field of Quality Management / Regulatory Affairs or with Notified Bodies
- Excellent project management skills and very good knowledge of German and English, both written and spoken
- International diversity - in the team and in the projects.
- Long-term prospects - through professional and personal development, a wide range of tasks and individually tailored training opportunities even in the onboarding phase.
- Flexibility, freedom and personal responsibility - through flat hierarchies, short decision-making processes and family-friendly working time models, with something for everyone.
- One of the most beautiful regions in Germany, on the edge of the Black Forest in the border triangle of Germany / France / Switzerland.
- In addition, attractive salary, company pension plan, capital-forming benefits
Are you interested to find out more about this role? Please contact Vera-Lucia Bösch for further details:
Phone: +49 30 16 63 68 37