What you’ll do as a Design Quality Assurance Engineer
We are looking for a Design Quality Assurance Engineer who will be responsible for ensuring compliance with applicable standards and the ViCentra Quality Management System in relation to design and development processes, including risk management. As a Design Quality Engineer you'll be working with many different disciplines within ViCentra such as R&D, Product Management & Marketing, Quality Assurance and Regulatory Affairs, but also our Manufacturing organisation. You'll be the technical expert on quality issues related to product development. In this way you will play a key role in taking Kaleido to the next level and making our product ready for deployment!
At ViCentra we believe that a crucial part of this is staying close to our customers. We value their feedback and rely on it to continually improve and enhance our product. Our short lines of communication with our customers enable us to respond quickly and effectively. This helps us to deliver a product that truly meets their needs.
You will report to the Senior Design Assurance & NPI Manager and work in a team with other Design Quality Assurance Engineers.
Key responsibilities
• You’re responsible for design quality throughout the whole product development phase from design planning to design transfer (software and hardware related)
• You’ll be promoting continuous improvement in design control activities and use of quality tools with the R&D team
• You 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
• You support change control activities related to design and development and manufacturing changes
• You support the improvement of the risk management system; leading sessions, tracking and monitoring progress
• You lead or participate in non-conformances, CAPA and complaint investigation activities.
• You ensure compliance with the regulatory requirements applicable to ViCentra (such as ISO 13485, Regulation (EU) 2017.745, 21 CFR 820 and applicable technical standards) as well as with ViCentra’s internal procedures and work instructions.
About ViCentra, home of Kaleido
At ViCentra, our mission is to improve the quality of life for people with diabetes. We do this through our innovative, user-friendly solution: the Kaleido insulin pump which includes a hybrid closed loop system. Our vision is to empower people to focus on living their best lives by prioritizing simplicity, inclusivity, and personalized care in everything we do. Join us in reshaping diabetes management and making a meaningful difference in people's lives.
Who are you
• You have a Bachelor's degree in Quality, Mechanical, Biomedical engineering, Health Sciences, Industrial Design or similar and we think suited for someone with a minimum of 2-3 years of industry experience.
• You have knowledge of global Medical Device Regulations (EU MDR and FDA) regarding design & development
• You have knowledge of risk management according to ISO 14971
• You’re able to work autonomously and have a pragmatic and flexible approach as we’re working in a scale-up environment that is rapidly changing
• You’re someone who is pro-active, always looking for improvement and you’re not afraid to express yourself.
Don’t meet every requirement? We value potential and encourage you to apply!
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.