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