Quality Engineer

Founded in 2017 in Utrecht, Vitestro is pioneering the future of blood collection with the Aletta® Autonomous Robotic Phlebotomy Device™ (ARPD™). This groundbreaking medical device combines advanced multi-modal imaging (near-infrared, ultrasound, and Doppler ultrasound) with robotics and AI to perform the entire diagnostic blood draw procedure autonomously.

By addressing critical healthcare staffing shortages and improving patient experience, Vitestro is transforming one of the most common and essential medical procedures. With more than 90 team members and growing rapidly, we are scaling our impact. As we placed our first devices with customers, we are now expanding our team to ensure successful implementation and long-term reliability.

At Vitestro, we are committed to continuous innovation and improvement.

As our Quality Engineer, you play a key role in strengthening the quality foundation of our product development environment. You work closely with systems, software, and mechanical engineers to ensure quality processes are effective, practical, and aligned with the needs of a regulated medical device organization.

In your day-to-day work, your focus is on maintaining and improving quality processes, ensuring non-conformances are properly investigated and resolved, supporting tool validation, and facilitating risk management activities across development. You help engineering teams work in a structured and compliant way, while making sure quality requirements are translated into clear actions and practical improvements.

You take ownership of follow-up and process discipline, while collaborating across functions to keep quality embedded in the way we design, develop, and improve our product.

After 12 months, quality processes are running more consistently across the development organization. Non-conformances are handled in a timely and structured way, tool validation is better embedded in engineering workflows, and risk management activities are more visible and effective. You have become a trusted partner for engineering teams when it comes to quality, compliance, and process improvement.

• Bachelor’s degree in Engineering, Applied Science, or a related technical field.

• At least 3 years of experience working in regulated industries with strict quality and compliance requirements.

• Experience managing non-conformances, including investigation, follow-up, and resolution.

• Experience supporting or facilitating risk management activities.

• Experience working with mature QMS frameworks and qualification workflows.

• Strong communication skills and the ability to work effectively with cross-functional engineering teams.

• Fluent in English.

• Experience with medical device quality systems compliant with ISO 13485 and EU MDR.

• Python experience to support tooling used in quality-related processes.

• A flexible and open mindset, with a pragmatic “I will make it work” mentality.

• A strong drive to take ownership of your own development.

We offer an environment where you can make a lot of impact, as you are joining a growing scale-up in MedTech. Our team of driven and talented colleagues enjoys solving the challenges in developing, manufacturing, and completing our breakthrough medical device. While working in an open culture, we strive for excellence in all domains. We believe in taking courage and like to challenge each other. We learn and teach, regardless of age, nationality or gender.