Quality Assurance Specialist

Quality Assurance Specialist

Location: Frankfurt, Germany (hybrid)

Salary: 50k -55k EUR per year

We are currently partnering with a prominent international organisation in the medical device and IVD sector to recruit a European Quality Assurance Specialist based in Frankfurt, Germany. This is an excellent opportunity for a detail-oriented professional to play a pivotal role in maintaining compliance and quality excellence across European operations.

The Role

As the European Quality Assurance Specialist , you will work closely with the European QA Manager to develop and improve local ISO 9001 Quality Management systems. You will serve as the first point of contact for external parties, including authorities and distributors, regarding quality-related inquiries.

Key Responsibilities

• Quality Management: Support the development of the Quality Management Framework and manage quality system metrics.
• Operational Support: Assist in Quality Complaint Handling and provide documentation support for the implementation of quality and operational processes.
• Compliance & Audits: Ensure ongoing compliance with ISO 9001, ISO 13485, and IVDR regulations, while supporting internal audits and inspections.
• Supplier & Stakeholder Coordination: Coordinate responses to customer/distributor questionnaires and assist the wider QA group with GMP supplier qualifications.
• Training: Support and assist with quality training for all European employees.

Required Qualifications

• Education: Bachelor’s degree (B.Sc., B.Eng., or FH equivalent).
• Experience: 1–3 years of experience in Quality Assurance within a regulated environment (medical device, IVD, pharma, or similar).
• Language Skills: Fluent English and French, plus proficiency in German and Italian.
• Technical Proficiency: High proficiency in Power BI and Excel is required, along with experience using Microsoft Office Suite and SharePoint Online.
• Regulatory Knowledge: Strong working knowledge of ISO 9001, ISO 13485, and IVDR.
• Soft Skills: Excellent interpersonal and communication skills