Quality Engineer

ViCentra B.V.; De Meern; Hybrid; EUR 70,000 - 90,000; Full time

Job summary

ViCentra is seeking a Quality Engineer, Process Validation, to ensure validated, repeatable processes behind insulin pump technology and to scale them across production. You’ll collaborate with R&D, Manufacturing, Regulatory, suppliers, and CMOs to transfer from development to production with rigor and care.

You will drive IQ/OQ/PQ and TMV validation, apply statistics, and ensure compliance with ISO 13485, EU MDR, and QMSR while contributing to the QE team’s project delivery and quality culture.

Qualifications

• 3 to 5 years of experience in Quality Engineering in a regulated environment.
• 3 to 5 years of hands-on process validation (IQ/OQ/PQ, TMV).
• Solid knowledge of statistical techniques and data analysis.
• Strong understanding of ISO 13485, EU MDR and QMSR (21 CFR 820).
• Fluent written and spoken English; Dutch is not required.

Responsibilities

• Drive validation activities (IQ/OQ/PQ, TMV) on processes, methods, equipment and specifications.
• 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 improve 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 support decision making.
• Maintain compliance with ISO 13485, EU MDR, QMSR and internal procedures.
• Lead projects within the QE team and manage deadlines.

Skills

Quality Engineering

Process Validation

IQ/OQ/PQ

TMV

Education

Bachelor's in Quality/Mechanical/Biomedical Eng

Tools

Minitab

MS 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.