Quality Assurance Specialist

About the role

Join an international team dedicated to improving healthcare outcomes. As a Quality Assurance Specialist you will support the Quality department in ensuring product safety, regulatory compliance, and continuous improvement across the organization.

Key responsibilities

• Manage and investigate product complaints, perform risk assessments and determine reportability to Health Authorities.
• Create and maintain complaint‑related quality procedures and follow up on corrective actions.
• Conduct audits to verify proper case classification and prepare trend reports.
• Maintain the vigilance and post‑market surveillance system, report adverse events, and manage recalls, FSCA and FSN in line with regulations.
• Participate in defining vigilance procedures and develop post‑market plans and reports.
• Support the Quality Management System (ISO 13485, IVDR, MDSAP) by contributing to improvement projects and external audits.
• Handle temperature excursions in shipments and manage required documentation for distributors.
• Participate in supplier evaluation, qualification, audits and draft quality agreements.
• Coordinate and supervise team activities when applicable and support the Head of Department.

Required profile

• Experience in handling product complaints and conducting investigations.
• Knowledge of health‑authority reporting and post‑market surveillance processes.
• Familiarity with regulatory frameworks such as ISO 13485, IVDR, MDSAP, 21 CFR 820 and 21 CFR 600.
• Ability to perform audits, generate trend analyses and manage corrective actions.
• Strong organizational skills to maintain documentation and support supplier management.

Required skills

• ISO 13485
• IVDR
• MDSAP
• 21 CFR 820
• 21 CFR 600