16 Aug
|
Zeiss India
|
Bengaluru
16 Aug
Zeiss India
Bengaluru
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 (Bengaluru)
🏢 Zeiss India
📍 Bengaluru