You will be responsible for risk analyses and software FMEAs for medical devices in accordance with ISO 14971, act as an interface between customers and development teams and ensure standard-compliant processes and documentation in accordance with MDR and ISO 13485.

You coordinate verification and validation activities for medical software projects in accordance with IEC 62304, ISO 13485 and MDR, ensure traceability in the V-model and act as an interface between development, QA and customers.