Quality Specialist

About the role

We are looking for a Quality Specialist to lead and maintain our Quality Management System (QMS) for medical devices, ensuring compliance with international standards and driving a culture of patient safety.

Key responsibilities

• Implement, maintain and monitor the site QMS, ensuring compliance with ISO 9001, ISO 13485 and other applicable regulations.
• Lead audit readiness, coordinate internal and external audits, and oversee corrective action implementation.
• Deliver and coordinate mandatory quality training and maintain competency records.
• Track and report quality metrics such as complaints, CAPA, non‑conformances, inspection findings and field corrective actions.
• Promote a patient‑safety culture and ensure staff adherence to quality policies.
• Collaborate with Operations, Regulatory and Commercial teams to support smooth execution and risk mitigation.
• Oversee field service procedures, distribution, storage, cold‑chain management and product integrity.
• Integrate customer feedback, complaints and returns into the QMS.
• Ensure labeling, documentation and local regulatory requirements for shipped devices are met.

Required profile

• Demonstrated ability to build trust, adapt to changing situations and drive results.
• Strong decision‑making skills and capacity to balance stakeholder needs.
• Collaborative mindset with strategic thinking and innovation orientation.
• Leadership qualities with personal ownership and willingness to challenge decisions when appropriate.

Required skills

• ISO 9001
• ISO 13485
• Quality Management System (QMS) implementation and maintenance
• CAPA management
• Audit coordination and corrective‑action oversight

What we offer

• Gross annual salary between €35,000 and €45,000, paid over 14 months with fixed and variable components.
• Employee benefits and career‑growth opportunities, including mentoring programs.