Quality Systems & Technical Documentation Specialist – Medical Device Software (SaMD/SiMD)

Permanent employee, Full-time · Munich

55,000 - 75,000 € per year

Your mission

As a Quality Systems & Technical Documentation Specialist in our Quality Management team, you will support the creation of technical documentation for both our in-house SaMD product and customer projects where our software is integrated into medical device systems (SiMD), especially in the area of interventional navigation and planning.

You will work closely with our software development teams and contribute to scalable documentation processes aligned with ISO 13485, MDR and FDA expectations.

Your responsibilities

Create technical documentation for customer solutions developed using our SDK together with our software development teams
Create the technical documentation for our in-house SaMD, ensuring MDR/FDA-ready documentation structures
Improve internal tooling and processes to deliver documentation faster and increase efficiency
Maintain and continuously improve our QMS in alignment with ISO 13485
Contribute to internal and external audits by preparing documentation, evidence, and traceability artifacts

Your profile

Experience in quality, technical documentation, or regulated documentation in medical device software (SaMD and/or SiMD)
Familiarity with ISO 13485 and documentation expectations under MDR and/or FDA
Experience in collaborating with software development teams and translating technical content into compliant documentation
Strong attention to detail, structured working style, and good communication skills
Exposure in medical imaging, navigation and interventional clinical workflows is a strong plus

Why us?

Be part of an international, dynamic, and highly qualified team where you can make a real impact and shape the future together with us
Enjoy the agility of a start-up combined with the security of an established company
Receive a competitive salary and a comprehensive benefits package (e.g., bike leasing, sports programs, Deutschlandticket, etc.)
We celebrate successes together at various team events such as our summer party or Oktoberfest

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About us

ImFusion GmbH is a growing company located in Munich, conducting research, development and consulting in advanced medical image computing technologies and computer vision. Our customers include small and large medical device companies as well as academic research labs. We wish to expand our team with talented and motivated people.

We are an equal opportunity employer and are committed to creating an inclusive and diverse workplace where everyone feels valued and empowered. We celebrate diversity and welcome applications from people of all backgrounds, regardless of race, religion, color, national origin, gender, gender identity, sexual orientation, age, marital status, disability, or any other legally protected characteristic. Our goal is to foster a culture of belonging, where different perspectives drive innovation and success.

You think you can be a good fit? We'd love to hear from you!

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We are looking forward to your application!

Thank you for your interest in ImFusion!

Please fill out the following form. Should you have difficulties with the upload of your data, please send an email to jobs@imfusion.com

We’d love to stay in touch with you – even if it doesn’t work out this time.
If you're happy for us to do so, we'd like to keep your application on file in our talent pool for up to 24 months after the current process concludes. This allows us to contact you should a future opportunity match your profile.