European Quality Assurance Specialist

About the role

We are seeking an European Quality Assurance Specialist to join our European QA team. Based in Mörfelden‑Walldorf, you will work closely with the European QA Manager and cross‑functional stakeholders to maintain and enhance quality systems within a regulated environment.

Key responsibilities

• Support European sites and shared services in documenting and implementing quality and operational processes.
• Assist in maintaining ISO certifications and ensuring compliance with ISO 13485, ISO 9001 and GMP requirements.
• Monitor quality metrics, prepare training materials and drive compliance activities across Europe.
• Collaborate with internal teams to address audit findings and promote continuous improvement.
• Participate in internal and external audits, and contribute to corrective and preventive actions.

Required profile

• Strong interest in quality assurance within the life‑science or medical‑device sector.
• Experience working in a regulated environment and familiarity with European regulatory standards.
• Ability to work independently and coordinate with multiple stakeholders across different countries.

Required skills

• Knowledge of ISO 13485.
• Knowledge of ISO 9001.
• Understanding of Good Manufacturing Practice (GMP) principles.

What we offer

• Opportunity to contribute to cutting‑edge biopharmaceutical and diagnostic technologies.
• Collaborative, mission‑driven culture with focus on innovation and professional growth.