Senior Design Assurance Quality Engineer — Diabetes Care Impact

Kaleido; Utrecht; Vor Ort; EUR 60.000 - 80.000; Vollzeit

Benefits dieser Stelle

Culture of innovation

Commitment to integrity

Creative freedom

Zusammenfassung

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.

Qualifikationen

• 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.

Aufgaben

• 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.

Kenntnisse

Quality Engineering experience

Compliance knowledge

Collaboration skills

Data analysis proficiency

Problem-solving skills

Ausbildung

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

Tools

Minitab or similar software

Jobbeschreibung

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.