Your Role

• 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

• Very good communication and team skills

• Good knowledge of German and English

Your ZEISS Recruiting Team: