Quality Manager Specialist (f/m/x)

at  ZEISS Group

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:
Sabrina Rieke

• 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 Affair