Job DescriptionSr. QMS Manager – Quality & Digital Systems: NPosition 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). NPrimary duties and responsibilities NQMS 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 NAudit 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 NManagement 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 NDigital 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 NContinuous improvement: N
- Analyze quality data, audit outcomes, deviations, and KPIs to identify improvement opportunities N
- Lead and support cross-functional improvement initiatives across NC/CAPA, document control, complaints, and deviation management N
- Promote a culture of quality excellence and sustainable process improvement NTraining and support: N
- Design and support QMS-related training programs across systems and processes N
- Provide expert guidanceto stakeholders on regulatory and QMS requirements N
- Strengthening organizational capability through coaching and best practice sharing NExternal interfaces: N
- Support engagement withnotified bodies, certification bodies, and external auditors N
- Ensure structured preparation and execution of external inspections and audits NEducation / Professional Certification: N
- Bachelor's or Master's degree in engineering, natural sciences, or related field N
- Strong knowledge of ISO13485, ISO 9001, MDSAP, and GxP requirements N
- Lead Auditor certification is a plus NExperience: N
- 3–7 years of experiencein Quality Management within regulated industries (medical devices, pharma, or equivalent) N
- Proven experience in QMS operations, audits, and compliance management N
- 3–5 years of exposure to digital quality systems (eQMS platforms) N
- 3–5 years of experiencein Computer System Validation (CSV) is a strong advantage NKnowledge / Skills / Other characteristics: N
- Robust understanding ofQMS frameworks and regulatory requirements N
- Solid knowledge of audit methodologies and CAPA lifecycle management N
- Hands-on experience with eQMS platforms (e.G., TrackWise, Veeva, Dot Compliance) N
- Strong analytical, problem-solving, and data interpretation skills N
- Excellent stakeholder management and communication skills N
- Ability to operate effectively in global, cross-functional environments N
- Fluent English required; German is an advantage

📌 Sr. Qms Manager - Quality & Digital Systems (Bengaluru)
🏢 Zeiss India
📍 Bengaluru