20 Aug
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Zeiss India
|
India
Sr. QMS Manager – Quality & Digital Systems: Position summary: 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 • Strengthen overall audit readiness across regions, ensuring consistent compliance performance Management reporting: • Lead preparation and analysis of QMS performance metrics for management review • Support structured execution of Management Review Meetings, including tracking of resulting actions • Manage and govern Change Review Board (CRB) processes, ensuring effective evaluation and controlled implementation of quality-relevant changes Digital quality systems: • Drive design, implementation, validation, and lifecycle management of digital quality systems (eQMS, RIMS, and related platforms) • Ensure full compliance with Computer System Validation (CSV) principles and data integrity requirements • Enable digital transformation of QMS processes through harmonized system architecture and governance Continuous improvement: • Analyze quality data, audit outcomes, deviations, and KPIs to identify improvement
📌 Sr. QMS Manager – Quality (India)
🏢 Zeiss India
📍 India