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
Your Profile
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
