A leader in transfusion diagnostics are are looking for a QA/RA Specialist to support the Snr Director of QA/RA in their Frankfurt HQ.
Responsibilities:
- Contribute to quality oversight by adhering to ISO 13485, ISO 9001, IVDR, and cGMP standards.
- Ensure IVD products meet regulatory requirements.
- Evaluate release testing against specifications and coordinate sample submissions to notified bodies.
- Review online documentation (e.g. TrackWise) to ensure proper records.
- Address deviations, CAPAs and other quality-related issues by performing root cause analysis.
- Initiate, review, and approve various documents (e.g., OOSS, protocols, reports).
- Support the Document Management System EU.
- Conduct internal and external audits.
- Assist with product registration and CE marking in Europe.
- Ensure proper documentation and adherence to quality regulations.
Requirements:
- Minimum 2 years professional experience in QA / RA in the field of medical devices or IVD
- Experience with ISO 13485, ISO 9001, ISO 14971 and IVDR / MDR.
- Fluency in German and English
- Quality certifications such as Six Sigma Green preferred.
- Highly motivated and personable attitude.
