(Senior) Quality Engineer – Design Assurance

Kaleido; Utrecht; On-site; EUR 60,000 - 80,000; Full time

Benefits offered by this job

Culture of innovation

Commitment to integrity

Creative freedom

Job summary

A medical technology company in Utrecht seeks a (Senior) Quality Engineer to ensure high standards in product design and compliance within a highly regulated environment. The ideal candidate has a relevant Bachelor's degree and over 5 years of experience in Quality Engineering, particularly in medical devices. You will collaborate with teams across the organization to improve quality and safety in diabetes care innovations.

Qualifications

• 5+ years of experience in Quality Engineering in a regulated industry.
• Deep knowledge of Design Control processes and phases.
• Excellent grasp of ISO 13485 and EU MDR regulations.

Responsibilities

• Ensure robust design quality and compliance from development to design transfer.
• Lead risk management and quality investigations.
• Support change control activities related to development changes.

Skills

Quality Engineering experience

Compliance knowledge

Collaboration skills

Data analysis proficiency

Problem-solving skills

Education

Bachelor’s degree in Quality, Mechanical, or Biomedical Engineering or equivalent

Tools

Minitab or similar software

Job description

(Senior) Quality Engineer – Design Assurance

Join to apply for the (Senior) Quality Engineer – Design Assurance role at ViCentra

At ViCentra, we’re on a mission to redefine what’s possible in diabetes care. 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.

As a (Senior) Quality Engineer – Design Assurance at ViCentra, you’ll be the technical linchpin ensuring our products exceed the highest standards of quality and safety. Your expertise will be central to every stage of product development, making you a driving force behind our mission to make life easier for people with diabetes.

You'll take ownership of quality across design, manufacturing, and the introduction of new and improved products and processes. Acting as a trusted partner to R&D, Manufacturing, Product Management, and Regulatory Affairs, you'll help shape products and processes that truly make a difference. We’re a fast‑paced, highly regulated environment and therefore are looking for a motivated self‑starter who’s happy to take ownership and isn’t afraid to jump in when problems come up.

What you’ll take on

• Ensure robust design quality and compliance from development through design transfer (hardware and software), collaborating closely with R&D.
• Partner with Manufacturing, R&D, Quality, Regulatory, suppliers, and CMOs to develop and improve quality controls and documentation.
• Work closely with the R&D team to establish system‑design requirements, specifications and verification & validation activities; actively support and engage in design reviews.
• Support change control activities related to design, development and manufacturing changes.
• Lead and participate in risk management, quality investigations (non‑conformities, complaints, CAPAs), and process improvements.
• Deliver quality‑related training and support internal, supplier, and external audits.
• Maintain compliance with applicable regulations (ISO 13485, EU MDR, 21 CFR 820) and internal standards.
• Deliver lasting impact: As part of the team within Quality & Regulatory Affairs, your work won’t just support individual projects—you’ll help raise the bar for quality across our entire organization.

What you bring

• A bachelor’s degree in Quality, Mechanical, or Biomedical Engineering, Health Sciences, or equivalent practical experience.
• At least 5 years of proven experience in Quality Engineering, preferably within a medical device or regulated industry.
• Deep knowledge of Design Control processes and phases, including V&V activities such as DV testing, usability, shipment & shelf‑life testing, IEC 60601, biosafety, etc.
• Excellent grasp of relevant regulations: ISO 13485, EU MDR, and 21 CFR 820.
• High proficiency in Microsoft Office and solid general IT skills.
• Fluent written and spoken English. (Dutch is not required.)
• Experience in a start‑up or scale‑up environment.
• Familiarity with cleanroom standards and/or sterilization processes (Gamma, EtO).
• Experience with Minitab or similar data analysis/statistics software.
• Experience in process validation (IQ/OQ/PQ).

Benefits

• Culture of innovation: we experiment, challenge norms, and learn fast.
• Commitment to integrity: honesty, openness shape our relationships.
• Customer‑first mindset: every idea is measured by the impact on those we serve.
• Drive for excellence: we hold ourselves to the highest standard because lives depend on it.
• Creative freedom, supportive teamwork, and room to lead initiatives.
• Direct impact in people’s lives, today and into the future.
• Opportunity to work with a highly motivated, diverse team of innovators.