Quality Manager Operations (m/w/x)

Trust something new, grow beyond itself and redefine the boundaries of the feasible. That is exactly what our employees can and should live daily. To make a sign with our innovations and to enable great. Because there are a lot of fascinating people behind every successful company. In an open and modern environment with numerous development and further training opportunities, ZEISS employees work in a culture characterised by expert knowledge and team spirit. All this is supported by the special ownership structure and the long-term goal of the Carl-Zeiss Foundation: to advance science and society together. Today dare. Inspire tomorrow. Diversity is part of ZEISS. We look forward to your application regardless of gender, nationality, ethnic and social origin, religion, world view, disability, age as well as sexual orientation and identity. Apply in less than 10 minutes.

Seeing beyond - future of medical technology For more than 100 years, the medical technology of ZEISS has been driving progress in ophthalmology and microsurgery. In ophthalmology, our solutions help to maintain and improve the vision of people at any time of life. In microsurgery, our solutions enable targeted interventions on the diseased tissue, so that small and sensitive organs continue to function optimally ZEISS's medical technology supports medical professionals to improve the lives of patients worldwide. The fact that we have a direct influence on the well-being of our people is our daily drive.

Your job They support an assigned product family in series production and accompany quality-relevant topics on the remaining product life

You evaluate the impact of quality problems, especially regarding product safety & field contact

They influence delivery stops and CAPA; e.g. for Field Corrective Actions (FCA)

They evaluate assigned customer complaints and decide on necessary investigations and measures and carry out effectiveness testing of improvement measures as well as the introduction of preventive measures to avoid errors by

You release production specifications (DMR – Device Master Record) and changes to specifications (DHF – Design History File)

They define test specifications and application of goods receipt check plans (SAP) taking into account the CP (Control Plan), FMEA, NC (Non-Conformance) and PMS (Post Market Surveillance)

They carry out safety-critical individual checks in the receipt of goods and release the product-specific test specifications when new or changed

They support the implementation of internal product audits and the preparation and monitoring of external audits

Technical/natural science degree

Specialized professional experience in the development and development of quality management and quality improvement measures, ideally in the field of medical technology

Experience with problem-solving methods of quality management according to 13485 (8D, CAPA)

competent knowledge of medical technology standards, in particular in quality management, including ISO 13485:2016; 21CFR820, Laws and Regulations (MDR 2017/745)

Experience in moderation and interaction with partner teams and interfaces in the intercultural environment

Very good communication skills and team skills

Flowing English and German in Word and Written

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