Sr. QMS Manager – Quality & Digital Systems

ZEISS India · Greater bengaluru area, India

Sr. QMS Manager – Quality & Digital Systems:

Position summary:

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.

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