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Quality Engineer - Design Assurance
QTC are partnered with a leading medtech scale-up based in Utrecht focused within the world of continouous glucose monitoring to identify strong profiles related to Design Assurance to join a small hands-on team to drive compliant and practical solutions for their new and existing product range.
Details
Medical Devices
Quality/RA
De Meern - Netherlands
40 hours per week
Get to know
Your consultant
About your role
This is how you will make the difference
This role will act as the technical quality owner during product development, design transfer and post-market support. This includes design control, verification, risk management and manufacturing readiness for both hardware/software, reusable systems and mobile applications. Additional responsibilities include:
- Review and approve design control documentation across all phases.
- Lead/support usability, mechanical, shelf-life and biosafety testing.
- Ensure V&V strategy meets EU MDR, FDA and risk-based requirements.
- Lead risk management activities (ISO 14971) with engineering
- Collaborate with suppliers and manufacturing partners to define and maintain quality controls.
what's needed
What you bring
Requirements:
- Bachelor's degree in Engineering, Quality or Life Sciences.
- 5+ years of Quality Engineering experience in medical devices or regulated industry.
- Strong experience with design control and V&V (including usability, mechanical,shelf-life, biosafety).
- Solid experience with risk management (ISO 14971).
- Familiarity with IEC 60601, ISO 10993.
- Strong documentation and QMS knowledge.
What we offer
What's in it for you
Offer:
- Join a innovative scale-up environment working with an international team
- Take ownership from day one and directly see the actions of your work
- Modern office with flexible hybrid work pattern
- Competitive benefits package including strong incentives plan
Send your application