EU Quality & Compliance Lead: QMS, MDR & Audits

ZEISS Group; Birmingham; On-site; GBP 90,000 - 130,000; Full time

Job summary

ZEISS Group seeks a senior Quality & Regulatory professional to lead EU QMS governance across Medical Devices, cosmetics, and related products. You will ensure compliance with EU quality frameworks and align product lifecycle activities with MDR, ISO 13485, and ISO 14971 requirements.

In this role you will drive governance, supplier quality interfaces, and post-market vigilance, while supporting audits, CAPAs, and regulatory submissions within a matrix organization.

Qualifications

• 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 organisations with outsourced manufacturing models.
• Experience in audit and inspection environments.

Responsibilities

• Lead QMS governance and oversee EU QMS for Consumer Eyecare.
• Ensure compliance with EU regulatory requirements and product lifecycle needs.
• Act as Quality partner for post-market activities and governance.
• Collaborate on scalable QMS processes, supplier quality, and CAPA management.
• Maintain audit readiness and support inspections by authorities.

Skills

QMS governance

EU MDR knowledge

ISO 13485

ISO 14971

GDP

Regulatory compliance

Audit & inspection experience

Job description

ZEISS Group seeks a senior Quality & Regulatory professional to lead EU QMS governance across Medical Devices, cosmetics, and related products. You will ensure compliance with EU quality frameworks and align product lifecycle activities with MDR, ISO 13485, and ISO 14971 requirements.

In this role you will drive governance, supplier quality interfaces, and post-market vigilance, while supporting audits, CAPAs, and regulatory submissions within a matrix organization.