Sr. QMS Manager – Quality (Bangalore Metropolitan Area)

Sr. QMS Manager – Quality (Bangalore Metropolitan Area)

18 Aug
|
Zeiss India
|
Bangalore Metropolitan Area

18 Aug

Zeiss India

Bangalore Metropolitan Area

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 t

📌 Sr. QMS Manager – Quality (Bangalore Metropolitan Area)
🏢 Zeiss India
📍 Bangalore Metropolitan Area

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