EU Quality Manager

ZEISS is technology and innovation. We develop, manufacture and sell highly innovative products and solutions for our customers in a variety of business fields – always testing the limits of what is feasible.

ZEISS is an internationally leading technology enterprise operating in the optics and optoelectronics industries generating more than 11.8 billion euros in revenue with around 46,000 employees across 50 countries around the globe.

Position Summary

• Lead and maintain the EU Quality Management System (QMS) for Consumer Eyecare across product categories including Medical Devices Class IIa, food supplements, cosmetics, and where applicable OTC medicinal products
• Ensure products placed on the EU market are compliant with applicable EU quality, safety, and regulatory requirements
• Act as the key Quality partner for product lifecycle, QMS governance, and post-market quality activities
• Support a scalable and compliant Quality framework for the EU business
• Ensure alignment with EU regulatory frameworks, including EU MDR (2017/745), ISO 13485, ISO 14971, GDP, Cosmetics Regulation (EC) No 1223/2009, and Directive 2001/83/EC and EU GMP (EudraLex Volume 4) where applicable.

Responsibilities

Quality Management System (QMS) Oversight

• Own and continuously improve the EU QMS, including governance, standards, and processes
• Ensure effective implementation of core QMS elements: document control, training, deviations, CAPAs, change control, complaints, recalls, and management review
• Ensure compliance with ISO 13485 and application of ISO 14971 risk management principles
• Ensure inspection readiness and compliance with regulatory expectations
• Ensure data integrity (ALCOA+) and appropriate documentation practices

Supply Chain Quality – Governance & Interface

• Define and maintain QMS requirements for supplier and contract manufacturing oversight
• Ensure that appropriate quality processes (e.g., qualification, audits, quality agreements, change control) are defined within the QMS framework
• Act as governance and escalation point for critical supplier-related quality issues
• Review and assess quality impact of major deviations, trends, or systemic issues arising from external manufacturing
• Ensure alignment with the Supplier Quality function while not owning operational supplier management or audits
• Ensure that QP release and GMP expectations are appropriately reflected in QMS processes where medicinal products are in scope

Regulatory Compliance & Labelling

• Ensure QMS and processes are aligned with EU regulatory frameworks across all product categories
• Provide Quality oversight for labeling compliance:
• Cosmetics Regulation (EC) No 1223/2009
• Food supplement regulations
• Directive 2001/83/EC for OTC/non-prescription medicinal products
• Act as the Quality interface to Regulatory Affairs and the Person Responsible for Regulatory Compliance (PRRC)
• Ensure audit-ready documentation and traceability of regulatory-relevant processes

Post-Market Surveillance & Vigilance

• Ensure QMS processes support compliant complaint handling, PMS, and vigilance activities
• Oversee that MDR PMS and vigilance requirements (FSCA, FSN, EUDAMED) are implemented and effective
• Ensure pharmacovigilance processes for medicinal products are embedded and compliant within the QMS framework
• Monitor quality data and trends at a system level to identify systemic risks
• Act as escalation point for critical product quality and compliance issues

Audits, Inspections & Governance

• Lead QMS-related internal audits and ensure audit readiness
• Support external audits and inspections by notified bodies and competent authorities
• Ensure effective CAPA management and closure at system level
• Lead Management Review and Quality governance processes
• Escalate systemic risks and ensure appropriate corrective actions

Required Knowledge & Experience

• Strong experience in QMS governance within EU regulated environments
• Experience across medical devices, consumer healthcare, food supplements, and/or cosmetics
• Strong knowledge of EU MDR, ISO 13485, ISO 14971, GDP
• Understanding of EU pharmaceutical framework (Directive 2001/83/EC, EU GMP) where applicable
• Experience working in organizations with outsourced manufacturing models
• Experience in audit and inspection environments
• Strong QMS governance and system thinking
• Ability to operate in a matrix organization with clear role boundaries
• Strong risk assessment and decision-making capabilities
• Ability to translate regulatory requirements into scalable QMS processes
• Strong stakeholder management and escalation capability
• Clear distinction between governance and operational execution (especially regarding Supplier Quality)

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