Quality Control Engineer

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

Our client is an innovative company operating in the medical technology sector. The companydevelops solutions designed to support healthcare professionals and improve patient care.

Quality Control Engineer (M/F/X)

Responsibilities

As a Quality Control Engineer, you will play a key role in ensuring the quality, conformity and readiness of the company's medical devices and manufacturing activities at its Belgian site.

You will be responsible for product testing and release, the assembly and packaging of single-use products, supplier and contract-manufacturer quality activities, process validation, equipment qualification, warehouse and inventory management, and quality system activities.

Working within an ISO 13485:2016 certified QMS, you will collaborate closely with Quality Assurance, Service, Regulatory Affairs, Supply Chain and R&D teams to ensure robust manufacturing and quality processes.

• Supplier and incoming quality: review supplier and contract-manufacturer records, verify completeness, traceability and conformity to specifications, perform incoming inspections and manage the release, quarantine or rejection of materials. Support non-conformity investigations, corrective actions and supplier improvement.
• Product testing and release: perform final acceptance, functional and performance testing, calibration, software/firmware verification and product configuration before release. Maintain relevant quality records, investigate failures and ensure successful re-testing.
• Manufacturing and packaging: plan and execute the assembly, kitting, labelling and packaging of single-use medical device products, ensuring compliance with production requirements, traceability, shelf-life, storage conditions and applicable regulations.
• Production and continuous improvement: maintain and improve manufacturing instructions, batch records, bills of materials and in-process controls. Monitor production KPIs and drive improvement actions related to yield, scrap, rework and cycle time.
• Warehouse and inventory: manage goods receipt, storage, picking, packing and dispatch; maintain accurate ERP inventory, perform stock counts, monitor stock levels and ensure appropriate storage, handling and segregation of materials.
• Validation and equipment qualification: execute IQ/OQ/PQ activities for manufacturing, packaging, labelling and product testing processes, and support the qualification, calibration and maintenance of production and testing equipment. Support the transfer of new products and design changes into routine manufacturing.
• Quality Management System: support ISO 13485 activities including document control, non-conformities, CAPA and change control. Maintain complete, traceable and audit-ready quality records and follow up on quality actions.
• Quality and compliance: support complaint investigations, post-market activities, quality reporting, audits and regulatory inspections by providing relevant manufacturing, testing and traceability information.
• Cross-functional collaboration: work closely with Quality Assurance, Service, Regulatory Affairs, Supply Chain and R&D teams to continuously improve manufacturing and quality processes.

Profile

• Bachelor's degree in Industrial, Mechanical, Biomedical, Electromechanical or Manufacturing Engineering, or equivalent experience.
• 2–3 years of experience in medical device manufacturing or another regulated environment, with hands‑on experience in assembly, testing and inspection.
• Good knowledge of ISO 13485, including documentation, traceability, non-conformities, CAPA, complaints and change control.
• Experience with process validation (IQ/OQ/PQ), equipment qualification, calibration and maintenance.
• Experience with warehouse/inventory management and ERP systems.
• Able to read technical drawings, specifications and test protocols, with a rigorous, hands‑on and well‑organised approach.
• Fluent English is mandatory; Dutch and/or French is an asset.
• Experience in regulated manufacturing, eQMS, continuous improvement or regulatory audits is an asset.

Offer

• A hands‑on and diversified position within a growing and innovative MedTech company.
• The opportunity to contribute directly to the development and continuous improvement of the company's manufacturing and quality processes.
• To work in a human size, dynamic, respectful, and professional environment.
• International exposure, with learning and development opportunities.
• An attractive compensation package in line with your responsibilities and experience.

Your application will be handled confidentially, in accordance with the GDPR. PaHRtners promotes diversity, equity, and inclusion.