Senior QA & Change Control Lead - Medical Devices

Vitestro; Utrecht; Hybrid; EUR 70,000 - 90,000; Full time

Benefits offered by this job

Competitive salary

Pension plan

25 days annual leave

Hybrid work model

Team in Utrecht

Annual company weekend away

Training budget

Job summary

Vitestro, based in Utrecht, is seeking a Senior QS Officer to drive continuous improvement of quality systems and support the Change Control process within a regulated medical-device environment.

You will review processes, guide colleagues through change control, and develop practical, compliant solutions that strengthen both compliance and efficiency. A systematic, analytical mindset and 3–5 years in QA/QMS are essential.

Qualifications

• Bachelor’s degree or higher in engineering, applied sciences, biomedical engineering, or similar technical field.
• Minimum 3 to 5 years experience in Quality Assurance / Quality Systems for medical devices.
• Experience working in a regulated environment.
• A systematic, process-oriented way of working.

Responsibilities

• Focus on continuous improvement of our quality systems and support the Change Control process.
• Guide colleagues through change control, ensuring proper approvals and timely completion.
• Identify opportunities to improve compliance and efficiency of the Change Control process.
• Develop practical solutions and alternative approaches that comply with regulatory requirements.

Skills

Analytical thinking

Process orientation

Problem solving

Adaptable mindset

Education

Bachelor’s degree or higher in engineering or related technical field

Tools

MDSAP

Job description

Vitestro, based in Utrecht, is seeking a Senior QS Officer to drive continuous improvement of quality systems and support the Change Control process within a regulated medical-device environment.

You will review processes, guide colleagues through change control, and develop practical, compliant solutions that strengthen both compliance and efficiency. A systematic, analytical mindset and 3–5 years in QA/QMS are essential.