Auditor EN ISO 13485, ISO 9001 and MDSAP (f/m/x)

Regulatory bodies, hospitals, health care practitioners and patients expect the devices used to treat and heal illnesses and injuries to be safe and to perform as promised.

Join us in our mission to assist our customers in producing and operating the most effective, technologically sophisticated and safest products for the medical sector.

As an Auditor, you ensure that our customers’ medical products meet the highest safety standards. In detail, that means:

You primarily conduct audits based on the EC Directive 93/42/EC; 98/79/EC and the standards EN ISO 13485, ISO 9001 and according to international schemes such as MDSAP and TCP.

• You compile reports and audit documentation.
• You are responsible to review technical documentations of selected product groups in the active medical device area in your field of expertise, such as dental medical devices, active surgical, ophthalmic or electrophysiological devices.
• You support our medical technology customers with your professional expertise.

• Degree course in natural sciences or engineering
• At least four years of professional experience, at least two years of which are in the development, production, quality assurance, or approval of medical products
• 2 years of experience in development, production, quality assurance, regulatory affairs or quality management of medical devices
• Auditor training is a plus
• Relevant experience on production technologies such as:
• • Joining technologies (special processes which require validation, e.g. welding, gluing, brazing and soldering)
  • Metals (machining, grinding, cutting, finishing, etc.)
  • Thin and thick film manufacturing (electronic devices such as surface mount devices, sensors and printed circuit boards)
• Fluent in English, willingness to travel and Class B driver’s license
• Local and international business trips are required (depending on country specific conditions up to 70% per month)

If you do not have auditor training, we can of course offer you further training to become an Auditor/Lead Auditor.

We offer you varied and exciting tasks. We offer an attractive working environment. We support you with extensive further training opportunities. And the many advantages of a globally active company are a matter of course.

We would be delighted if we could win you and your knowledge over to us. Just send us your online application and let us know what your salary expectations are. We look forward to hearing from you.