Quality Assurance Specialist

About the role

We are looking for a motivated and detail‑oriented Quality Assurance Specialist to join our Quality team. The role focuses on maintaining and improving our Quality Management System for IVD products and culture media, ensuring regulatory compliance and supporting audits.

Key responsibilities

• Run, update and audit QMS processes in line with ISO 13485 and IVDR (EU 2017/746).
• Prepare, update and monitor technical documentation for Class A‑D nucleic acid extraction kits, Real‑Time PCR kits and culture media.
• Manage environmental monitoring, validation, calibration and hygiene control for ISO Class 7 cleanrooms.
• Investigate deviations and non‑conformances, initiate CAPA processes and ensure closure.
• Participate in Notified Body, ISO 13485 and internal audits.
• Conduct risk‑based assessments of changes to raw materials, processes, equipment and documentation.
• Execute supplier evaluation, approval and audit processes.

Required profile

• Master’s or PhD in Molecular Biology, Biotechnology, Bioengineering or related life‑science field.
• Minimum 1 year of QA experience in the medical device/IVD industry.
• Strong knowledge of ISO 13485 implementation; internal auditor certification preferred.
• Hands‑on experience with IVDR and preparation of technical documentation.
• Good knowledge of ISO 14971 risk management.
• Fluent English for documentation review and audits.

Required skills

• ISO 13485
• IVDR (EU 2017/746)
• ISO 14971
• CAPA management
• Cleanroom environmental monitoring
• Technical documentation preparation