Senior Quality Assurance Specialist

il y a 3 semaines


Laeken, Belgique Panda International Temps plein

Location: Brussels, Belgium Contract: Full-time, permanent We are partnering with a leading IVD company to find a Senior Quality Assurance Specialist. This company is an established international IVD distributor supporting hospitals and global export markets. The organisation offers a collaborative environment with growth across Quality Assurance, Regulatory Affairs, and Product Management. Role Overview As Senior Quality Assurance Professional, you will ensure the quality, safety, and compliance of the IVD products across their full lifecycle. You will work within an ISO 13485 and IVDR-compliant QMS and act as a key link between Quality, Regulatory, Product Management, and suppliers. Key Responsibilities Lead CAPA, non-conformities, complaints, and risk management (ISO 14971) for IVD products. Manage change control, technical documentation updates, and product lifecycle activities. Support IVDR and export market product registrations with required quality documentation. Maintain QMS documentation and support internal audits, mock recalls, and PMS activities. Coordinate with suppliers and internal teams on product quality and documentation. Ensure accuracy of product master data in ERP systems. Qualifications Bachelor's/Master's in Life Sciences, Quality, Engineering or similar. 4+ years' experience in IVD or medical device companies (ISO 13485, IVDR). Strong skills in CAPA, complaints, documentation, and risk management. Familiarity with ERP/QMS tools; strong technical writing ability. Fluent in English (Dutch or French is a plus); proficient in MS Office. What You Can Expect International environment focused on high-quality IVD products. Collaborative, supportive team culture. Apply To discuss this opportunity or express your interest, please send your CV to c.ruiz@panda-int.com or apply via LinkedIn.


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