Sr. QMS Manager - Quality & Digital Systems
ZEISS India
Job Description
Job Description
Sr. 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 guidance to stakeholders on regulatory and QMS requirements
\n• Strengthening organizational capability through coaching and best practice sharing
\nExternal interfaces:
\n• Support engagement with notified bodies, certification bodies, and external auditors
\n• Ensure structured preparation and execution of external inspections and audits
\n\nEducation / Professional 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
\nExperience:
\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
\nKnowledge / 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