Quality Assurance Specialist (European)

About the role

The European Quality Assurance Specialist will support the European QA Manager in developing and maintaining ISO‑based quality systems for a leading medical device and IVD organisation. This hybrid position in Frankfurt serves as the primary contact for regulators, distributors and other external stakeholders on quality matters.

Key responsibilities

• Support the development and continuous improvement of the Quality Management Framework and monitor system metrics.
• Assist with quality complaint handling and provide documentation for operational processes.
• Ensure ongoing compliance with ISO 9001, ISO 13485 and IVDR, and support internal audits and inspections.
• Coordinate responses to customer and distributor questionnaires and aid GMP supplier qualifications.
• Help deliver quality training for all European employees.

Required profile

• Bachelor’s degree (B.Sc., B.Eng. or FH equivalent).
• 1–3 years of QA experience in a regulated environment such as medical devices, IVD or pharma.
• Fluent in English and French, with proficiency in German and Italian.
• Strong working knowledge of ISO 9001, ISO 13485 and IVDR regulations.
• Excellent interpersonal and communication skills.

Required skills

• Power BI
• Excel
• Microsoft Office Suite
• SharePoint Online