Vigilance & Complaint Manager (m/f/x) - limited for two years

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 set the pace with our innovations and make it great. Because there are a lot of fascinating people behind every successful company. ZEISS employees work in an open and modern environment with numerous development and further training opportunities. Our culture is characterized 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 now! 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. Detection of complaints, assessment of criticality and ensuring compliance with reporting deadlines according to local and global requirements (e.g. EU MDR, FDA 21 CFR).

Cause analysis and coordination with specialist departments to identify and initiate countermeasures to improve product quality

Process-compliant processing of safety correction measures in the field

timely notification of vigilance activities and communication with global authorities

Conducting statistical analyses and creating trend reports for health authorities and internal processes

Planning and control of (cross-functional) subprojects

Participation in maintaining the QM system according to ISO 13485:2016 and the development, standardization and continuous improvement of vigilance and complaint management processes

Cooperation with other departments and cooperation to overarching processes such as post-market surveillance

completed university studies, preferably in a technical or scientific degree course (e.g. medical technology, pharmaceutical technology, optometry) or equivalent professional experience in combination with a corresponding degree

Professional experience in the development and development of quality management measures as well as quality improvement in Vigilance or Post Market Surveillance, ideally in the field of medical technology

fluent English skills in word and writing are required; ideally, you will bring knowledge of another foreign language with

well-founded knowledge of medical technology standards, in particular in quality management, such as ISO 13485:2016, as well as relevant laws and regulations, including MDR 2017/745, 21 CFR 820, 803 and 806

Experience in the analysis of regulatory requirements and use of databases

basic knowledge of statistics and database analysis are advantageous

Knowledge in creating dashboards with Power BI is desirable

an independent, structured and sustainable way of working completes your profile

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