Vigilance & Complaint Manager (m/w/x)

Karlsruhe, Germany

Join ZEISS - Pioneering Medical Technology

At ZEISS, we empower our employees to challenge themselves, grow beyond limits, and redefine what is possible. We lead with innovation and enable greatness, supported by a culture rooted in expertise and teamwork, underpinned by the long-term vision of the Carl Zeiss Foundation to advance science and society.

We value diversity and encourage applications from all backgrounds, regardless of gender, nationality, ethnicity, religion, worldview, disability, age, sexual orientation, or identity.

About ZEISS Medical Technology

For over 100 years, ZEISS has been advancing medical technology in ophthalmology and microsurgery, helping to preserve and improve eyesight and enabling precise interventions in delicate tissues to maintain organ function.

Our solutions aim to enhance patient lives worldwide, driven by the tangible impact of our work on well-being.

Key Responsibilities:

• Capture and evaluate complaints, assess criticality, and ensure compliance with reporting deadlines per local and global standards (e.g., EU MDR, FDA 21 CFR).
• Conduct root cause analyses and coordinate with relevant departments to implement corrective actions to improve product quality.
• Handle safety corrective actions in the field in accordance with process requirements.
• Ensure timely reporting of vigilance activities and communicate with global authorities.
• Perform statistical analyses and generate trend reports for health authorities and internal processes.
• Plan and manage cross-functional sub-projects.
• Maintain the QM system according to ISO 13485:2016 and contribute to the development and improvement of vigilance and complaint management processes.
• Collaborate with other departments and support overarching processes such as Post-Market Surveillance.

Qualifications:

• Degree in a technical or scientific field (e.g., Medical Technology, Pharmaceutical Technology, Optometry) or equivalent professional experience combined with relevant education.
• Experience in developing and improving quality management measures, especially in vigilance or post-market surveillance within medical technology.
• Fluent in English, both spoken and written; knowledge of additional languages is a plus.
• Strong knowledge of medical device standards, especially ISO 13485:2016, and relevant regulations such as MDR 2017/745, 21 CFR 820, 803, and 806.
• Experience analyzing regulatory requirements and working with databases.
• Basic knowledge of statistics and data analysis is advantageous.
• Familiarity with creating dashboards in Power BI is desirable.
• Self-motivated, structured, and sustainable working approach.