(Senior) Quality Engineer Design Assurance

Quality and safety aren’t just checkboxes for us, they’re the foundation of the trust our users place in us. To help us push boundaries while upholding the highest standards, we’re searching for an inspired and experienced (Senior) Quality Engineer – Design Assurance to join our passionate team.  
 

Your impact as a (Senior) Quality Engineer – Design Assurance 
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 pacing and highly regulated environment and therefore looking for a motivated self-starter who’s happy to take ownership and isn’t afraid to jump in when problems come up. You’ll spot issues, speak up, and help find practical solutions. In return, you'll get to work in a place where your efforts really make a difference and where you’ll play an important role in moving our Kaleido product line forward. 

 
Your key responsibilities: 

• DQA: 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. 

• DQA: Work closely with the R&D team to establish the system designs 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. 
   

Who we’re looking for 

You’re a pragmatic problem-solver with a passion for quality and results, ready to take on a key role in a fast-moving, mission-driven environment. We're looking for someone that is able to work independently and take initiative whilst collaborating with the business and focusing on our shared goals.

Your background and experience: 

• 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. 

• DQA: You bring strong understanding of Design Control process and phases, including V&V activities like DV testing, usability, shipment & shelf-life testing, IEC 60601, biosafety etc. 

• Deep knowledge of quality control principles, quality management systems (QMS), CAPA, risk management, and non-conformance processes. 

• 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.) 

 
Bonus points: 

• 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 softwar 

• DQA: Experience in Process validation (IQ/OQ/PQ) 

What we offer 

• Meaningful work, autonomy and a salary matching your level of experience. 

• 25 days of holiday per year and the opportunity to take the Dutch national holidays on any day that suits you 

• Participation in the company pension scheme 

• Subsidized gym membership, phone allowance, a tax friendly bike scheme and budget to facilitate a home office set-up 

• A diverse and inclusive work environment including a team of 45+ different nationalities.