Distribution Quality Engineer

Randstad is recruiting for a Distribution Quality Engineer to join the QA team responsible for distribution in the EMEA region, overseeing quality processes related to post-production, storage, and distribution of medical devices and pharmaceutical products.

• Higher education (preferably Bachelor of Science or related field)
• Fluent English (minimum C1 level) required for daily work in an international environment
• Practical knowledge of ISO 13485 and quality management systems (QMS)
• Experience in medical devices or pharmaceutical industry
• Preferred approximately 5 years of experience in QA/QMS, open to candidates with less experience but strong substantive skills
• Willingness to travel for audits within the EMEA region
• Excellent communication and interpersonal skills for working with distributed teams
• Basic knowledge of SAP or Oracle systems is a plus

• Supervise quality management systems in distribution centers (DC/3PL), external distributors, and service/repair points in the EMEA region
• Ensure process compliance with internal and international regulations including ISO 13485, ISO 14971, EU MDR, US 21 CFR 210/211/820
• Conduct audits at 3PL suppliers and logistics centers across EMEA, focusing over 60% on warehousing and storage
• Collaborate with Operations and Supply Chain departments to identify risks, continuously improve processes, and resolve quality issues
• Coordinate local activities such as material storage requirements, repackaging/over-labeling, and shipment holds

This job offer is intended for candidates over 18 years of age. Employment agency registration number: 47.