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Quality systems & technical documentation specialist – medical device software (samd/simd)

Moosach
ImFusion GmbH
55.000 € - 75.000 € pro Jahr
Inserat online seit: 25 Februar
Beschreibung

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 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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