QMS Manager Governance (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 duties You are the Subject Matter Expert in the field of regulatory requirements for computerized systems in regulated business (e.g.: CFR 21 Part 820 / Part 11)

They support the fields of computer system validation

They develop, implement, maintain, monitor and document validation strategies and the following measures

They conduct process owners and stakeholders in analyses and changes of processes of the Quality Management System (QMS) and ensure consistent processes and coordinated interfaces

They provide guidelines and guidelines on regulatory requirements for the QMS and manage the effective implementation in the processes of the QM system

They promote and train methodological competence and guide employees in the application of quality methods

They guide and support QMS projects for further standardization and continuous improvement, including the control of corrective and preventive measures

Completion of a 4-year university degree (Master), preferably in a scientific or business studies or equivalent professional experience combined with a corresponding Degree of study

Long-term professional experience, preferably in a medical device or pharmaceutical company or comparable regulated environment

Methodology competence (quality methods: FMEA, 5W, CAPA) and knowledge of regulatory requirements (ISO 13485, MDR)

Embossed communication, networking and analysis skills and escalation handling

Ability to target group-oriented communication - and motivation

Experience in the moderation and guidance of groups

Ability to think out of the box

Knowledge of relevant validation standards

Experience in project management and methodology is advantageous

Flowing German and English

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