Job Description

Sr. QMS Manager – Quality & Digital Systems:

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Position summary:

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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.

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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).

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Primary duties and responsibilities

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QMS maintenance and improvement

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• Own and support the lifecycle management and continuous improvement of the QMS in alignment with global regulatory standards

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• Identify systemic process gaps and drive structured risk-based assessments

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• Lead and support implementation of effective corrective and preventive actions (CAPA) to ensure long-term compliance and process stability

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Audit program support:

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• Lead planning, coordination, and execution of internal and external audits using a risk-based audit strategy

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• Ensure structured preparation, documentation, and timely closure of audit findings

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• Strengthen overall audit readiness across regions, ensuring consistent compliance performance

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Management reporting:

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• Lead preparation and analysis of QMS performance metrics for management review

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• Support structured execution of Management Review Meetings, including tracking of resulting actions

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• Manage and govern Change Review Board (CRB) processes, ensuring effective evaluation and controlled implementation of quality-relevant changes

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Digital quality systems:

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• Drive design, implementation, validation, and lifecycle management of digital quality systems (eQMS, RIMS, and related platforms)

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• Ensure full compliance with Computer System Validation (CSV) principles and data integrity requirements

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• Enable digital transformation of QMS processes through harmonized system architecture and governance

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Continuous improvement:

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• Analyze quality data, audit outcomes, deviations, and KPIs to identify improvement opportunities

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• Lead and support cross-functional improvement initiatives across NC/CAPA, document control, complaints, and deviation management

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• Promote a culture of quality excellence and sustainable process improvement

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Training and support:

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• Design and support QMS-related training programs across systems and processes

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• Provide expert guidance to stakeholders on regulatory and QMS requirements

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• Strengthening organizational capability through coaching and best practice sharing

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External interfaces:

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• Support engagement with notified bodies, certification bodies, and external auditors

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• Ensure structured preparation and execution of external inspections and audits

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Education / Professional Certification:

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• Bachelor's or Master's degree in engineering, natural sciences, or related field

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• Strong knowledge of ISO 13485, ISO 9001, MDSAP, and GxP requirements

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• Lead Auditor certification is a plus

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Experience:

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• 3–7 years of experience in Quality Management within regulated industries (medical devices, pharma, or equivalent)

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• Proven experience in QMS operations, audits, and compliance management

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• 3–5 years of exposure to digital quality systems (eQMS platforms)

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• 3–5 years of experience in Computer System Validation (CSV) is a strong advantage

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Knowledge / Skills / Other characteristics:

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• Strong understanding of QMS frameworks and regulatory requirements

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• Solid knowledge of audit methodologies and CAPA lifecycle management

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• Hands-on experience with eQMS platforms (e.g., TrackWise, Veeva, Dot Compliance)

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• Solid analytical, problem-solving, and data interpretation skills

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• Excellent stakeholder management and communication skills

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• Ability to operate effectively in global, cross-functional environments

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• Fluent English required; German is an advantage

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