Head of QA/RA

Job description

About Vitestro

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. Join us as our new Head of QA/RA.

We’re looking for an accomplished Quality & Regulatory leader to own our global QA/RA strategy and execution as we scale for commercial operations. In this role you will strengthen quality culture, transform the existing QMS framework into a high-performing, commercially supportive function, and lead global regulatory strategy.

In your first months, you’ll focus on:

• Define and execute multi-year QA/RA roadmap to support sustained compliance through near term commercial scale and global expansion
• Design and scale QA/RA organization, build a high-performing team
• Establish effective cross-functional partnership with R&D, Operations and Commercial, and external partners
• Architect legacy QMS framework into a user-friendly, scalable eQMS system designed for compliance and rigor; drive continuous QMS improvement efforts to ensure on-going compliance for QMS processes throughout the total product lifecycle
• Plan and lead audit program to ensure internal audits, supplier audits, and external audits/inspections (Notified Body and U.S. FDA) support QMS compliance
• Own global Regulatory Strategy definition and execution, including submission preparation, agency interactions, and lifecycle maintenance
• Fulfill Person Responsible for Regulatory Compliance (PRRC) obligations (EU MDR)

This is what your success looks like

After 12 months you have successfully prepared the company for compliant, commercial scaling. You have helped to further establish a culture of quality throughout the company supported by a user-friendly eQMS. You have orchestrated the design transfer to production and production validation in collaboration with R&D, Production and our outsourcing partners. You have achieved regulatory approvals and/or recertification in the U.S. and EU.

Job requirements

What you bring:

• 15+ years in QA/RA in the medical device industry, including 5+ years leading teams and owning function-level outcomes during a commercial growth/transition phase
• Demonstrated record of building or transforming the quality function from the ground up, including ability to scale a QA/RA team
• 5+ years of end-to-end QMS ownership (not limited to a single subsystem), responsible for driving organization-wide QMS improvement efforts
• Strong working knowledge of EU MDR and FDA QSR / 21 CFR 820, and quality system standards such as ISO 13485; exposure to MDSAP is a plus
• Demonstrated experience with active medical devices (e.g., robotics)
• Hands-on audit leadership with regulatory bodies including ownership of on-going inspection readiness, hosting audits/inspections, and driving successful remediation
• A track record of successful regulatory submissions for U.S. Class II/III and/or EU Class IIa/IIb/III medical devices (e.g., 510(k), De Novo)
• Experience with security/privacy frameworks relevant to connected products and data environments (ISO 27001, SOC 2, HIPAA, GDPR) preferred but not required
• Full-time availability, with at least 3 days per week onsite in Utrecht

What we offer:

• Competitive salary including pension plan
• 25 days of annual leave based on a full-time position
• Hybrid work model
• Working together in a high-skilled team with our home base in Utrecht
• Frequent out-of-work activities with our team, and annual company weekend away
• Annual training budget of €2000,-
• Opportunity to be key shaper of a new global industry niche: autonomous medical robotics

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.