21 Aug
|
Zeiss India
|
Bengaluru
21 Aug
Zeiss India
Bengaluru
Job Description
Sr. QMS Manager – Quality & Digital Systems:
n Position summary:
nThe 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.
nThis 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).
n Primary duties and responsibilities
n QMS maintenance and improvement
n• Own and support the lifecycle management and continuous improvement of the QMS in alignment with global regulatory standards
n• Identify systemic process gaps and drive structured risk-based assessments
n• Lead and support implementation of effective corrective and preventive actions (CAPA) to ensure long-term compliance and process stability
n Audit program support:
n• Lead planning, coordination, and execution of internal and external audits using a risk-based audit strategy
n• Ensure structured preparation, documentation,
and timely closure of audit findings
n• Strengthen overall audit readiness across regions, ensuring consistent compliance performance
n Management reporting:
n• Lead preparation and analysis of QMS performance metrics for management review
n• Support structured execution of Management Review Meetings, including tracking of resulting actions
n• Manage and govern Change Review Board (CRB) processes, ensuring effective evaluation and controlled implementation of quality-relevant changes
n Digital quality systems:
n• Drive design, implementation, validation, and lifecycle management of digital quality systems (eQMS, RIMS, and related platforms)
n• Ensure full compliance with Computer System Validation (CSV) principles and data integrity requirements
n• Enable digital transformation of QMS processes through harmonized system architecture and governance
n Continuous improvement:
n• Analyze quality
📌 Sr. QMS Manager (Bengaluru)
🏢 Zeiss India
📍 Bengaluru