MedTech QC Engineer - Build Safe Medical Devices

PaHRtners; Luik; Sur place; EUR 60 000 - 80 000; Plein temps

Avantages offerts par ce poste

International exposure

Human-sized environment

Competitive compensation

Résumé du poste

PaHRtners is seeking a Quality Control Engineer (M/F/X) at our Belgian site to ensure quality, conformity and readiness of medical devices and manufacturing activities.

You will perform supplier and incoming quality activities, product testing and release, and manage packaging, warehouse, and continuous improvement. Fluent English is mandatory; Dutch/French are assets. The role offers broad cross-functional collaboration and an international exposure within a growing MedTech environment.

Qualifications

• Bachelor's degree in Industrial, Mechanical, Biomedical, Electromechanical or Manufacturing Engineering
• 2–3 years in medical device manufacturing or regulated environments
• Knowledge of ISO 13485 incl. documentation, traceability, CAPA, complaints and change control
• Experience with IQ/OQ/PQ, calibration and maintenance
• Able to read technical drawings and test protocols
• Fluent English (Dutch/French asset)
• Experience with warehouse/inventory management and ERP systems

Responsabilités

• Supplier and incoming quality: review supplier records, verify traceability and conformity, manage release/quarantine/rejection; support investigations and supplier improvements
• Product testing and release: perform final acceptance, functional and performance testing, calibration, software verification and configuration; maintain records and re-test
• Manufacturing and packaging: plan and execute assembly, labeling and packaging of single-use devices; ensure compliance and storage conditions
• Production and continuous improvement: maintain manufacturing instructions, batch records, BOMs and in-process controls; monitor KPIs and drive improvements
• Warehouse and inventory: goods receipt, storage, picking, packing and dispatch; maintain ERP inventory and stock counts
• Validation and equipment qualification: IQ/OQ/PQ for manufacturing, packaging, labeling and testing; support calibration/maintenance; transfer of new products
• Quality Management System: support ISO 13485 docs, non-conformities, CAPA and change control; audit-ready records
• Quality and compliance: support investigations, post-market activities, quality reporting, audits and regulatory inspections
• Cross-functional collaboration: work with QA, Service, Regulatory Affairs, Supply Chain and R&D to improve processes

Connaissances

Fluent English

Technical drawings

IQ/OQ/PQ

Process validation

Equipment qualification

ERP systems

CAPA & documentation

Formation

Engineering degree

Outils

ERP systems

Description du poste

PaHRtners is seeking a Quality Control Engineer (M/F/X) at our Belgian site to ensure quality, conformity and readiness of medical devices and manufacturing activities.

You will perform supplier and incoming quality activities, product testing and release, and manage packaging, warehouse, and continuous improvement. Fluent English is mandatory; Dutch/French are assets. The role offers broad cross-functional collaboration and an international exposure within a growing MedTech environment.