Active Medical Device Auditor (m/f/d)
Job type: Permanent
Location: Germany
A leading global Medical Device Notified Body is now looking for Active Medical Device Auditors to join their growing team in Europe. You will play a key role in the company's growth strategy and business success. In addition, you will be able to make an immediate impact on their European operations with leading Med Tech manufactures.
Key responsibilities of the Active Medical Device Auditor include:
- As an auditor / product expert medical for active medical devices, you are responsible for auditing medical device manufacturers on the basis of EC Directive 93/42/EEC and Regulation (EU) 2017/745 and the standards EN ISO 13485 and EN ISO 9001.
- You will review the product documentation (technical documentation) in the field of active medical devices on the basis of the relevant regulations, e.g. EN 60601, EN 62304 ET seq. and relevant EC directives / regulations, including standard-compliant documentation.
- In addition, you will write reports and documentation for certification.
- You are the point of contact for our customers in the medical technology sector.
- Comprehensive training and appropriate further training are a matter of course for us. We support you in becoming an auditor / lead auditor and promote your professional training and further development in your product expertise.
Key requirements of the Active Medical Device Auditor include:
- Degree in natural sciences or engineering from a university/university of applied sciences (e.g. medical technology, electrical engineering)
- At least 4 years of professional experience. Of which at least 2 years in the field of development, production, quality assurance, quality management or regulatory affairs of active medical devices or software
- Experience in dealing with the EC Directives/EC Regulation for medical devices as well as the applicable standards for QM systems and medical devices
- Basic knowledge in the field of approval of medical devices
- Fluent in German and English (from B2.2) (spoken and written)
The position will be based in Kรถln. For further information about this position please apply.
