Sr. QMS Manager – Quality & Digital Systems

ZEISS India; Bengaluru; On-site; INR 1,800,000 - 3,000,000; Full time

Job summary

ZEISS India in Bengaluru seeks a Sr. QMS Manager – Quality & Digital Systems to shape and sustain the global QMS for medical devices. You will drive compliance with ISO 13485, ISO 9001, MDSAP, and GxP, lead audits, and oversee digital quality platforms.

Responsibilities include CAPA leadership, risk-based assessments, CSV/data integrity, training, and external-inspection readiness, with 3–7 years in regulated QMS environments and strong stakeholder communication.

Qualifications

• 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.
• 3–7 years in Quality Management within regulated industries.
• Experience with QMS operations, audits, and compliance management.
• 3–5 years exposure to digital quality systems (eQMS).
• Hands-on in Computer System Validation (CSV) is advantageous.

Responsibilities

• 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 CAPA implementation to ensure long-term compliance and stability.
• Plan, coordinate, and execute internal and external audits using a risk-based strategy.
• Ensure documentation and timely closure of audit findings and strengthen audit readiness.
• Drive design, implementation, validation, and lifecycle management of digital quality systems.
• Ensure compliance with CSV principles and data integrity requirements.
• Analyze quality data, audit outcomes, deviations, and KPIs to identify improvements.
• Lead cross-functional initiatives across NC/CAPA, document control, complaints, and deviation management.
• Design and deliver QMS training; guide stakeholders on regulatory and QMS requirements.
• Engage with notified bodies, certification bodies, and external auditors.

Skills

QMS

Audits

CAPA

CSV

eQMS

GxP knowledge

Regulatory compliance

Stakeholder management

Education

Bachelor's or Master's in Engineering or Sciences

Tools

TrackWise

Veeva

Dot Compliance

Job description

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
• 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
• 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