Job Description Sr. QMS Manager – Quality & Digital Systems:
n Position summary:
n 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.
n 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).
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 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
n Training and support:
n • Design and support QMS-related training programs across systems and processes
n • Provide expert guidance to stakeholders on regulatory and QMS requirements
n • Strengthening organizational capability through coaching and best practice sharing
n External interfaces:
n • Support engagement with notified bodies, certification bodies, and external auditors
n • Ensure structured preparation and execution of external inspections and audits
n Education / Skilled Certification:
n • Bachelor's or Master's degree in engineering, natural sciences, or related field
n • Strong knowledge of ISO 13485, ISO 9001, MDSAP, and GxP requirements
n • Lead Auditor certification is a plus
n Experience:
n • 3–7 years of experience in 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 experience in Computer System Validation (CSV) is a strong advantage
n Knowledge / Skills / Other characteristics:
n • Strong understanding of QMS 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