Sr. QMS Manager – Quality & Digital Systems

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