QMS Manager
On-siteBengaluru, Karnataka, India
Job Summary
Own and support the lifecycle management of the global Quality Management System (QMS) for medical devices across ZEISS Vision Care, driving structured risk-based assessments and corrective actions. Lead planning and execution of internal and external audits, ensuring timely closure of findings and consistent compliance performance with ISO 9001, ISO 13485, MDSAP, and MDR. Drive the design, implementation, and validation of digital quality systems (eQMS, RIMS) while governing Change Review Board processes and managing management review meetings. Analyze quality data and KPIs to identify improvement opportunities and lead cross-functional initiatives across NC/CAPA, document control, and deviations. Design QMS-related training programs and provide expert guidance to stakeholders on regulatory requirements. Bachelor's or Master's degree in engineering or natural sciences required, with 3–7 years of experience in QMS operations within regulated industries; Lead Auditor certification is a plus. Fluent English required.
Required 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
- 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)
- 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
Desired Qualifications
- Lead Auditor certification is a plus
- German is an advantage
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