Wisst International Consulting GmbH | Germany | 77xxx Offenburg | Contractor position | Part time - flexible / Home office | Published since: 14.04.2026 on stepstone.de
Advanced Quality Engineer / Divisional Quality Engineer (MedTech) - Freelance
Wisst International Consulting GmbH (short: WIC) is a service company in the field of project management. Our offer includes everything related to project management. We do not only advise. We become part of the team with our customers, support our expertise and industry expertise and are "hands-on" operatively active in the projects of our customers. Join our mission and lead projects to success! !
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Your tasks • Your profile • What we offer
We are looking for highly motivated and dedicated Quality Engineers (freelance) to control design and development activities in the regulated MedTech environment. The focus is on design controls, risk management and ensuring regulatory compliance across the entire development process on the customer side.
Availability: 1-2 years, 50-60% Remote with punctual on-site terminals
Your tasks Review and approval of technical drawings Creation and maintenance of Design History Files (DHF) Construction and completion of Risk Management Files (RMF) Definition and assessment of verification and validation activities (V&V) Moderation of Design Reviews Support and advice on design control and regulatory requirements
Experience in regulated MedTech environment Design Controls, DHF, Risk Management Quality management according to standard (e.g. ISO 13485, ISO 14971) V&V methodology and technical documentation Experience in supplier quality and interface management English fluent, German from advantage Structured, independent operation Strong interface and communication capability Analytical thinking
Location
 | Wisst International Consulting GmbH | |
| 77652 Offenburg | ||
| Germany |
The text of this ad was translated from German into English using an automatic translation system and may contain semantic and lexical errors. Therefore, it should be used for introductory purposes only. For more detailed information, see the original text of the ad at the link below.
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