Quality Assurance Engineer
Elekta is seeking a Quality Assurance Engineer to support process owners in defining and implementing process and system changes that improve efficiency and strengthen the local quality management system. The role involves working across functions, ensuring compliance with medical device regulations, and contributing to audits and continuous improvement. The position is remote, based in Veenendaal, Utrecht, Netherlands, and requires experience in quality, regulatory affairs, or engineering, preferably in a medical device environment.
What you'll do
- Contribute to projects and value streams, helping ensure activities and deliverables meet applicable quality and regulatory requirements.
- Prepare monthly quality metrics for your area of responsibility and analyse process data and trends to identify opportunities for improvement.
- Represent the organisation in relevant quality and operational processes, such as corrective and preventive action, order fulfilment and manufacturing.
What you need
Must-have
ISO 13485ISO 14971ISO 14001IEC standardsMDDMDRUS FDA quality system requirementsQuality tools and techniquesProblem solving
Nice-to-have
LeanSix SigmaDesign of experimentsStatistical methods
Soft skills
CommunicationCollaborationIndependencePrioritizationIntegrityContinuous improvement
Quality AssuranceMedical DeviceRegulatory AffairsISO 13485AuditingRemoteFull-timeHealthcareEngineering