To embark on this career journey, you'll need:
- Completed medical, scientific, or engineering degree in higher education or technical college.
- At least 4 years of full-time employment with relevant practical experience in the medical device or pharmaceutical industry, science, laboratories, research centres or bodies that test or manufacture medical devices themselves; thereof at least 2 years of work-related experience in quality management.
- Verifiable knowledge of the norms DIN EN ISO 9000, subsequently DIN EN ISO 13485 as well as other norms that may form the basis of quality management systems (ISO 9001, ISO 19011)
- It is important for us to assign experts and managers with practical experience in auditing.
We're looking for expertise in the following areas:
- Non-active medical devices
- Active medical devices and
- Active Implantable Medical Devices: Cochlear Implants, MEMS systems, Implantable infusion pumps
Our success is based on our highly qualified and experienced auditors. They have completed professional training and/or a degree, have extensive experience with management techniques and management systems, and have proven practical experience in the various industries they audit
Training will be provided to ensure your success as an auditor
• ISO 13485 Lead Auditor Course • MDSAP (Medical Device Single Audit Programme) • MDR Regulation Training
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