Senior Design Assurance Quality Engineer — Diabetes Care Impact

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

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.