Summary
✨ AI‑Generated
A medical technology organization is seeking an experienced quality engineer to manage quality processes, investigations, audits, and improvement initiatives for regulated products.
Highlights
Hands-on quality role with ownership across the product lifecycle, continuous improvement activities, and opportunities for professional growth.
Description
Quality Engineer | Medical Devices | Netherlands
A leading global medical device manufacturer is hiring an experienced Quality Engineer for its site in the Netherlands.
Its products directly improve people's independence and quality of life every day.
The role is open because the previous person was promoted internally.
That says a lot about the career paths here, and so does the fact that many colleagues have stayed for 20+ years.
This is a varied, hands-on Quality Engineering role with real ownership.
You'll work across the full quality lifecycle, from post-market activity to continuous improvement and QMS management.
What you'll do
Drive quality activities across the product lifecycle, making sure products meet regulatory and customer requirementsLead investigations and root cause analysis, and drive CAPA and 8D through to closureSupport post-market quality activities, including product feedback and field issuesPlan and support internal and external auditsMaintain and improve the Quality Management SystemSpot trends, risks and improvement opportunities, and lead improvement projects across the businessAct as a key quality contact for customers, suppliers, Regulatory and authoritiesWho you'll work with
Quality, Regulatory, R&D, Service, Product Management, Purchasing and SalesCustomers, suppliers and competent authorities, in both Dutch and EnglishWhat you'll bring
Bachelor's degree (HBO level) or equivalent, ideally with further training in Quality Assurance or engineering5+ years in a quality role within medical devices or another regulated or technical manufacturing environmentKnowledge of ISO 13485 and EU MDR is preferred.
Strong ISO 9001 experience from industries such as automotive, bicycle or other technical manufacturing will also be consideredHands-on experience with quality tools such as CAPA, RCA, 8D and auditsFluent Dutch and strong EnglishAnalytical, structured and calm under pressure, with the confidence to communicate diplomatically across functions and with external parties
Desired Skills and Experience
Quality Engineer, Medical Device, 13485, ISO 13485, QA, Audits, Device, Medical manufacturing
