Quality Engineer
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 requirements
- Lead investigations and root cause analysis, and drive CAPA and 8D through to closure
- Support post-market quality activities, including product feedback and field issues
- Plan and support internal and external audits
- Maintain and improve the Quality Management System
- Spot trends, risks and improvement opportunities, and lead improvement projects across the business
- Act as a key quality contact for customers, suppliers, Regulatory and authorities
Who you'll work with
- Quality, Regulatory, R&D, Service, Product Management, Purchasing and Sales
- Customers, suppliers and competent authorities, in both Dutch and English
What you'll bring
- Bachelor's degree (HBO level) or equivalent, ideally with further training in Quality Assurance or engineering
- 5+ years in a quality role within medical devices or another regulated or technical manufacturing environment
- Knowledge 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 considered
- Hands-on experience with quality tools such as CAPA, RCA, 8D and audits
- Fluent Dutch and strong English
- Analytical, structured and calm under pressure, with the confidence to communicate diplomatically across functions and with external parties
FAQs
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