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

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 fas...