Qms Manager

**ZEISS in India** ZEISS in India is headquartered in Bengaluru and present in the fields of Industrial Quality Solutions, Research Microscopy Solutions, Medical Technology, Vision Care and Sports & Cine Optics. ZEISS India has 3 production facilities, R&D center, Global IT services and about 40 Sales & Service offices in almost all Tier I and Tier II cities in India. With 2200+ employees and continued investments over 25 years in India, ZEISS’ success story in India is continuing at a rapid pace.  Further information at [ZEISS India](https://www.zeiss.co.in/corporate/home.html). **Position summary:** The 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:** * Strong 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 Your ZEISS Recruiting Team: Itishree Pani