SUMMARY OF DUTIES

The Quality Engineer is responsible for supporting and maintaining the Quality Management System within a European medical device distribution centre. This role ensures that distribution, storage, handling, product release, nonconformance, complaint escalation, CAPA, and quality improvement activities are performed in compliance with applicable regulatory requirements, company procedures, ISO 13485 expectations, EU MDR distributor obligations, and customer requirements.DUTIES & RESPONSIBILITIES

• Support day-to-day quality oversight of receiving, inspection, storage, picking, packing, shipping, returns, quarantine, and product release activities within the distribution centre.
• Verify that distributed medical devices meet applicable requirements before release, including CE marking, product labelling, instructions for use, UDI, importer information where applicable, and required documentation.
• Ensure storage and transportation conditions remain aligned with manufacturer requirements, including temperature, humidity, segregation, cleanliness, and protection from contamination or damage.
• Manage or support nonconformance investigations, deviations, product holds, quarantine decisions, and disposition activities in collaboration with Operations, Regulatory Affairs, Supply Chain, and Quality leadership.
• Support complaint intake, escalation, investigation coordination, trend review, and communication with manufacturers or responsible economic operators as required.
• Initiate, investigate, and follow up on corrective and preventive actions, including root cause analysis, effectiveness checks, and timely closure.
• Perform process monitoring, quality data analysis, and trend reporting for distribution-related quality indicators.
• Support internal audits, external audits, notified body audits, competent authority inspections, and customer audits by preparing records, responding to findings, and driving remediation actions.
• Maintain and improve local quality procedures, work instructions, forms, training materials, and quality records.
• Participate in change control, risk assessment, validation, equipment qualification, calibration, and process improvement activities impacting distribution quality.
• Promote a quality and compliance culture by providing coaching, training, and technical guidance to warehouse and distribution personnel.
• Performs other related duties and tasks as required.

SUMMARY OF MINIMUM QUALIFICATIONS

• Bachelor’s degree in Engineering, Life Sciences, Quality Management, Regulatory Affairs, Supply Chain, or a related technical discipline.
• Minimum 5 years of experience in Quality, Manufacturing, Distribution, Regulatory, or Supply Chain within the medical device, pharmaceutical, life sciences, or other regulated industry.
• Working knowledge of ISO 13485, EU MDR requirements for distributors, nonconformance management, CAPA, complaint handling, and audit readiness.
• Experience supporting warehouse, distribution, logistics, product release, traceability, or post-market quality processes.
• Strong written and verbal communication skills in English; additional Dutch is preferred.
• Proficiency with electronic QMS, ERP, warehouse management systems, Microsoft Office, and data analysis tools.