Quality Engineer

Kaleido; Utrecht; Hybrid; EUR 60,000 - 90,000; Full time

Job summary

ViCentra in Utrecht, the Netherlands, seeks a Quality Engineer, Process Validation to ensure our insulin pump processes are proven, repeatable and scalable. You will drive IQ/OQ/PQ activities across processes, methods, equipment and specs, collaborating with R&D, Manufacturing, Regulatory, suppliers and CMOs to transfer and scale products.

You will apply statistical methods to validation data, maintain ISO 13485 and EU MDR compliance, and contribute to project management within the QE team,

Qualifications

• Bachelor's degree in Quality, Mechanical or Biomedical Engineering, Health Sciences, or equivalent practical experience.
• 3–5 years of experience in Quality Engineering, preferably in medical devices or another regulated industry.
• 3–5 years of hands-on process validation experience (IQ/OQ/PQ, TMV).
• Solid knowledge of statistical techniques and experience with Minitab or similar data analysis software.
• Deep understanding of quality control principles, quality management systems and risk management.
• Excellent grasp of ISO 13485, EU MDR and QMSR (21 CFR 820).
• Fluent written and spoken English; strong MS Office and IT skills.

Responsibilities

• Drive IQ/OQ/PQ validation activities on processes, methods, equipment and specs.
• Bring a quality lens to product and process development and design transfer.
• Collaborate with Manufacturing, R&D, Quality, Regulatory, suppliers and CMOs to 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 inform decisions.
• Maintain compliance with ISO 13485, EU MDR and QMSR (21 CFR 820).
• Contribute to project management and potentially lead QE projects.

Skills

Quality engineering

Process validation

Statistical analysis

Quality management

ISO/Regulatory knowledge

English proficiency

Collaboration

Detail oriented

Education

Bachelor's degree in Quality, Mechanical or Biomedical Engineering, Health Sciences, or equivalent

Tools

Minitab

Microsoft Office

Job description

Join ViCentra – Empower Bold Change in MedTech

Location: Utrecht, the Netherlands
Hybrid

Making Every Move Matter

AtViCentra, 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.

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.

What You Bring

• A Bachelor's degree in Quality, Mechanical or Biomedical Engineering, Health Sciences, or equivalent practical experience.
• 3 to 5 years of experience in Quality Engineering, preferably within medical devices or another regulated industry.
• 3 to 5 years of hands‑on process validation experience (IQ/OQ/PQ, TMV).
• Solid knowledge of statistical techniques and experience with Minitab or similar data analysis software.
• Deep understanding of quality control principles, quality management systems and risk management.
• Excellent grasp of ISO 13485, EU MDR and QMSR (21 CFR 820).
• Fluent written and spoken English (Dutch is not required), plus strong Microsoft Office and general IT skills.
• A self‑starting, resolution‑focused mindset, with a sharp eye for detail and strong collaboration skills.
• Experience with Design Control, cleanroom standards or sterilisation processes (Gamma, EtO), or a start‑up or scale‑up environment, is a strong plus.

Life at ViCentra

Working at ViCentra means joining a team defined by:

• Courage to create:We experiment, challenge norms, and learn fast.
• Trust above all:Integrity, honesty, and openness shape our relationships.
• Customer‑first mindset:Every idea is measured by the impact on those we serve.
• A drive for excellence:We hold ourselves to the highest standard because lives depend on it.

Our days move fast, fueled by curiosity, diverse perspectives, and a love for collaboration. Here, you can shape and be shaped by groundbreaking work in MedTech.

Grow With Purpose

• Harness your talent for a mission that truly matters.
• Enjoy creative freedom, supportive teamwork, and room to lead initiatives.
• Make a direct impact in people’s lives, today and into the future.
• Be surrounded by innovators who challenge and cheer you on.

Every Journey Starts Somewhere — Make Yours Count Here

We believe a powerful team is built on unique backgrounds and points of view. If this opportunity excites you but you’re unsure if you fit every bullet, we want to hear your story. At ViCentra, it’s your potential and passion that catch our eye.