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Quality Manager Specialist (f/m/x)
ZEISS
München
Feste Anstellung VollzeitStellenbeschreibung
In a spacious modern setting full of opportunities for further development, ZEISS employees work in a place where expert knowledge and team spirit reign supreme. All of this is supported by a special ownership structure and the long-term goal of the Carl Zeiss Foundation: to bring science and society into the future together.
Join us today. Inspire people tomorrow.
Diversity is a part of ZEISS. We look forward to receiving your application regardless of gender, nationality, ethnic and social origin, religion, philosophy of life, disability, age, sexual orientation or identity.
Apply now! It takes less than 10 minutes.
Your role
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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
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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
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Support and coordinate risk management activities according to ISO 14971 together with interdisciplinary teams
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Check the project status and negotiate with the team needed measures
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Participate in project milestones and approval of milestone decisions from a quality management perspective
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Carry out complaint management and, if necessary, support initiating reports to authorities and management
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Contribute to the post-market-surveillance activities needed for the product.
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Work closely with colleagues from Quality Management, Development, Product Management, Information Security and Regulatory and Clinical Affairs
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Degree in computer science, business administration or comparable degree
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Several years of professional experience in software development or in product development of medical devices in the field of quality management
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Strong understanding of quality and work independently and goal-oriented
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Very good communication and team skills
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Good knowledge of German and English
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