Quality Assurance Engineer III
Core
Ensuring compliance of medical device distribution, storage, and release processes within a European distribution center.
Role type
Quality Assurance Engineer (Medical Devices Distribution)
Builds
Compliant distribution and storage of medical devices for global hospitals
Domain
Medical Devices / Regulatory Compliance / Logistics
Deliverable
client delivery
Required skills
ISO 13485, EU MDR, CAPA, root cause analysis, audit management, quality data analysis, change control, risk assessment, validation, equipment qualification
Preferred skills
Dutch language proficiency
Technologies
Electronic QMS, ERP, warehouse management systems, Microsoft Office, data analysis tools
Responsibilities
Oversee receiving, inspection, storage, picking, packing, shipping, returns, quarantine, and product release activities; Verify product release requirements including CE marking, labelling, UDI, and documentation; Manage nonconformance investigations, deviations, product holds, and quarantine decisions; Support complaint intake, escalation, and investigation coordination; Initiate and follow up on corrective and preventive actions (CAPA); Perform process monitoring and quality data analysis for distribution indicators; Support internal, external, and customer audits; Maintain and improve local quality procedures and training materials; Participate in change control, risk assessment, and process improvement activities; Provide coaching and training to warehouse and distribution personnel.
Seniority
Mid-Senior, hands-on IC
