QA Lead: GDP & ISO 13485 for Medicines & Devices

airliquidehr; Zemst; Sur place; EUR 70 000 - 95 000; Plein temps

Résumé du poste

Air Liquide Belgium is seeking a Quality Assurance Lead to maintain the Quality Management System in line with GDP and ISO 13485 / MDR for medical devices and medicines. You will lead document management, CAPA, audits, changes, and supplier qualifications within the Benelux context.

You will ensure training, QA awareness, and oversee storage conditions, FEFO expiry management, and pest control at Zemst, collaborating with the Benelux Quality & Safety Manager to harmonize processes.

Qualifications

• Master in Science or equivalent.
• 3–5 years of professional experience in a quality environment related to medical devices and/or medicines.
• Excellent transversal leadership and structuring qualities.
• Open personality, reliable, and no-nonsense.
• Good Dutch and English language skills; French is a plus.

Responsabilités

• Maintain the Quality Management System according to GDP and ISO 13485 / MDR (Medical Devices as a distributor).
• Lead processes: document management, complaint and CAPA, external audits/inspections, internal audits, management of change, supplier qualification.
• Ensure training & qualification processes and raise quality awareness among personnel.
• Monitor storage conditions, expiry dates (FEFO), and pest control in Zemst; oversee supplier qualification/evaluation.
• Collaborate with the Benelux Quality & Safety Manager to harmonize quality processes between Belgium and the Netherlands.

Connaissances

Leadership

Communication

Quality awareness

Team player

Problem solving

Formation

Master in Science

Description du poste

Air Liquide Belgium is seeking a Quality Assurance Lead to maintain the Quality Management System in line with GDP and ISO 13485 / MDR for medical devices and medicines. You will lead document management, CAPA, audits, changes, and supplier qualifications within the Benelux context.

You will ensure training, QA awareness, and oversee storage conditions, FEFO expiry management, and pest control at Zemst, collaborating with the Benelux Quality & Safety Manager to harmonize processes.