QA Leader – Apeldoorn Region
We are looking for a QA Lead to join our team in the Apeldoorn region, focusing on maintaining quality assurance processes, including the QMS for warehousing and distribution, complaint handling, and product control.
Key Responsibilities:
* Oversee the QA team and manage the QMS (document control, training, corrective actions, non-conformance)
* Facilitate internal and external audits (ISO 13485, ISO 14001, warehouse certifications)
* Manage incoming inspections and the release of finished goods post sterilization (ETO, Gamma)
* Troubleshoot sterilization issues and support related projects
* Handle complaint investigations and manage customer questionnaires
* Perform warehouse quality checks, manage non-conforming products, and oversee repack/rework activities
Requirements:
* University degree with 2+ years of experience in a regulated industry (medical devices, pharma, biotech)
* Strong knowledge of ISO 13485 and European Good Distribution/Warehouse Practices
* Experience in warehouse environments preferred
* Excellent English communication skills (written and spoken)
* Self-driven, organized, and able to work independently or as part of a team
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