Support of quality management activities in an interdisciplinary and cross-location project team for software systems running on medical devices or medical software-only products, as advisor and supporter of the project manager and the project team

Analyze and review the product documentation, as well as approve and contributing product-specific and quality-oriented feedback, thereby ensuring the process-compliant development of the software

Support and coordinate risk management activities according to ISO 14971 together with interdisciplinary teams

Check the project status and negotiate with the team needed measures

Participate in project milestones and approval of milestone decisions from a quality management perspective

Carry out complaint management and, if necessary, support initiating reports to authorities and management

Contribute to the post-market-surveillance activities needed for the product

Work closely with colleagues from Quality Management, Development, Product Management, Information Security and Regulatory and Clinical Affairs

Degree in computer science, business administration or comparable degree

Several years of professional experience in software development or in product development of medical devices in the field of quality management

Strong understanding of quality and work independently and goal-oriented

Very good communication and team skills

Good knowledge of German and English

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