- Location
- Utrecht, Utrecht, Netherlands
- Workplace
- Hybrid
- Type
- Full-time
- Department
- QARA
- Seniority
- Mid
- Experience
- 3+ years
- Education
- Bachelor
- Source
- Recruitee
Description
📣 Join ViCentra – Empower Bold Change in MedTech
đź“Ť Location: Utrecht, the Netherlands
đź’Ľ Hybrid
🌍 Making Every Move Matter
At ViCentra, we’re on a mission to make living with diabetes easier, by designing simple, beautiful, and effective solutions that fit people’s lives, not the other way around. We combine technological innovation with human-centered design to empower people with more freedom, confidence, and life on their terms. Our values; Be Bold, Build Trust, Focus on the Customer and Deliver Excellence drive everything we create and every decision we make.
We believe that when ambition meets purpose, remarkable things happen. If you thrive in a space where ideas accelerate, challenges spark growth, and making a difference is the goal, ViCentra is your next great adventure. 🚀
đź‘©đź’» Your Impact
As Quality Engineer, Process Validation, you'll make sure the processes behind our insulin pump technology are proven, repeatable and ready to scale. You'll drive validation across processes, methods, equipment and specifications, working hand in hand with R&D, Manufacturing, Regulatory, suppliers and CMOs to bring products safely from development through design transfer and into production.
This is where rigour becomes trust. Every validated process is a promise to people living with diabetes that their device will perform, every time. As part of Quality & Regulatory Affairs, your work won't stop at individual projects: you'll help raise the bar for quality across the whole organisation as ViCentra grows.
🔧 What You’ll Take On
In your role, you will:
Drive and support validation activities (IQ/OQ/PQ, TMV) on processes, methods, equipment and specifications, including documentation review and approval.
Bring a quality lens to product and process development, design transfer and technology projects.
Partner with Manufacturing, R&D, Quality, Regulatory, suppliers and CMOs to develop and improve quality controls and documentation.
Develop and implement inspection processes and test methods.
Support Change Control for design, development and manufacturing changes.
Apply statistical techniques to analyse validation data and turn results into clear, defensible decisions.
Keep our work compliant with ISO 13485, EU MDR and QMSR (21 CFR 820), as well as internal procedures.
Contribute to project management, and potentially lead projects within the QE team, keeping deadlines and deliverables on track.