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 opportunities
- Lead and support cross-functional improvement initiatives across NC/CAPA, document control, complaints, and deviation management
- Promote a culture of quality excellence and sustainable process improvement

Training and support:

- Design and support QMS-related training programs across systems and processes
- Provide expert guidance to stakeholders on regulatory and QMS requirements
- Strengthening organizational capability through coaching and best practice sharing

External interfaces:

- Support engagement with notified bodies, certification bodies, and external auditors
- Ensure structured preparation and execution of external inspections and audits

Education / Professional Certification:

- Bachelor’s or Master’s degree in engineering, natural sciences, or related field
- Strong knowledge of ISO 13485, ISO 9001, MDSAP, and GxP requirements
- Lead Auditor certification is a plus

Experience:

- 3–7 years of experience in Quality Management within regulated industries (medical devices, pharma, or equivalent)
- Proven experience in QMS operations, audits, and compliance management
- 3–5 years of exposure to digital quality systems (eQMS platforms)
- 3–5 years of experience in Computer System Validation (CSV) is a strong advantage

Knowledge / Skills / Other characteristics:

- Robust understanding of QMS frameworks and regulatory requirements
- Solid knowledge of audit methodologies and CAPA lifecycle management
- Hands-on experience with eQMS platforms (e.g., TrackWise, Veeva, Dot Compliance)
- Strong analytical, problem-solving, and data interpretation skills
- Excellent stakeholder management and communication skills
- Ability to operate effectively in global, cross-functional environments
- Fluent English required; German is an advantage

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