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.

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