Senior Quality Engineer

ViCentra B.V.

  • Utrecht
  • Contract
  • Voltijds
  • 2 maanden geleden
  • Versneld solliciteren
What you’ll do as a Senior Quality Engineer – Supplier Management & Process ValidationDo you want to play a key role in ensuring the quality and reliability of innovative medical devices? As our Senior Quality Engineer, you will focus on Supplier Control and Process Validation, working with internal teams and external partners to ensure high-quality, compliant and reliable components and manufacturing processes. You’ll be instrumental in supporting ViCentra’s mission to deliver life-changing products to people with diabetes.In this role, you’ll work cross-functionally with Quality Control, Engineering, Manufacturing and Procurement, and report to the Senior Quality Control Manager.Key responsibilities
  • Collaborate with suppliers to identify and resolve quality issues, using root cause analysis and driving corrective and preventive actions.
  • Lead supplier performance monitoring, including defect rates, delivery reliability, and quality KPIs.
  • Take ownership of supplier evaluation, selection, auditing, and continuous improvement efforts.
  • Conduct or support audits (internal and external) and lead the review of process validation documentation (IQ/OQ/PQ).
  • Work closely with cross-functional teams to ensure supplier processes and components meet ViCentra’s specifications and regulatory standards.
  • Support CAPA/NCR investigations and risk management sessions, ensuring compliance and timely resolution.
  • Maintain high standards in quality documentation, procedures, and reporting.
  • Champion operational excellence by promoting strong relationships between internal teams and external suppliers.
  • Provide training and support to the organization on quality-related processes and practices.
About ViCentra, home of KaleidoAt ViCentra, we are committed to improving the lives of people with diabetes. We achieve this through our unique insulin pump — Kaleido — designed with simplicity, flexibility and user experience in mind. Our vision is to empower individuals to live confidently and freely, supported by innovative technology and personalized care. Join us in reshaping the future of diabetes management.Job RequirementsWho are you
  • Bachelor’s degree in Mechanical, Manufacturing, or Biomedical Engineering (or equivalent technical field).
  • 5+ years of experience in Quality Engineering or Supplier Quality in a regulated industry such as medical devices or pharmaceuticals.
  • Strong understanding of ISO 13485, MDR, 21 CFR 820, and GMP.
  • Proven experience in supplier auditing, root cause analysis, and process validation (IQ/OQ/PQ).
  • Excellent communication, analytical, and problem-solving skills.
  • Self-driven and detail-oriented, with a proactive mindset and the ability to thrive in a fast-paced environment.
  • Fluent in English, both written and spoken.
  • (Bonus) Experience with Minitab, cleanroom environments, or video measurement systems (e.g., Micro-Vu Vertex).
What we offer
  • A meaningful role in a mission-driven company with real impact.
  • Competitive salary, tailored to your experience.
  • 25 holidays per year with flexible national holiday scheduling.
  • Participation in our pension scheme.
  • Phone allowance, subsidized gym membership, and a tax-friendly bike scheme.
  • Budget to support your home office setup.
  • A diverse, inclusive, and supportive work environment with colleagues from over 45 nationalities.
Ready to help us raise the standard of diabetes care?
Apply now and be part of a bold and passionate team committed to delivering excellence.

ViCentra B.V.