The Sr. QMS Manager – Quality & Digital Systems plays a key role in shaping, maintaining, and continuously enhancing the global Quality Management System (QMS) for medical devices across ZEISS Vision Care.
This role ensures end-to-end compliance with applicable international standards and regulatory requirements (e.g., ISO 9001, ISO 13485, MDSAP, MDR and relevant GxP expectations).
Primary duties and responsibilities
QMS maintenance and improvement
• Own and support the lifecycle management and continuous improvement of the QMS in alignment with global regulatory standards
• Identify systemic process gaps and drive structured risk-based assessments
• Lead and support implementation of effective corrective and preventive actions (CAPA) to ensure long-term compliance and process stability
Audit program support:
• Lead planning, coordination, and execution of internal and external audits using a risk-based audit strategy
• Ensure structured preparation, documentation, and timely closure of audit findings