Senior Quality Systems Officer

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. As our Senior QS officer, you focus on the continuous improvement of our quality systems and support the company through the change control process. You review existing quality processes, identify where they can be improved or made more compliant, and help develop practical solutions to make those improvements happen. You also guide colleagues through change control. Rather than executing every change yourself, you ensure people understand and follow the process, ask the right questions, consider the relevant implications, obtain the necessary approvals, and ensure that changes are completed Correctly and on time. This role requires a strong analytical and systematic mindset combined with a pragmatic approach to quality. You should be comfortable identifying problems, but more importantly, finding workable solutions and alternatives. You understand the requirements of working in a regulated environment without approaching quality as simply enforcing rules. You are able to adapt, think creatively and help the organisation find compliant ways forward. First months at Vitestro (as in the example below) In your first months, you get to know Vitestro’s quality systems, processes, and the teams working with them. You build a thorough understanding of our Change Control process and start supporting colleagues through changes, helping them consider the right questions and ensuring changes are complete, appropriately approved, and progressing on time. As you become familiar with how we work, you identify opportunities to improve the compliance and efficiency of the Change Control process and develop a clear plan for implementing those improvements. This is what success looks like: After 12 months, you are a trusted partner for colleagues working with our quality systems and Change Control process. You confidently support the organization in executing changes, ensuring they are well considered, appropriately approved, and completed on time. You have improved the Change Control process to strengthen both compliance and efficiency, and have identified and implemented improvements across other areas of the QMS. You combine strong analytical thinking with a pragmatic and creative approach. You don’t just identify where something could be improved; you translate those insights into practical solutions and, when one approach doesn’t work, find alternative ways forward. What You’ll Bring: Strong analytical thinking and the ability to assess existing processes, identify where issues occur and determine how they can be improved. Experience working in a regulated environment. Relevant professional experience that provides an understanding of how quality systems and processes work. A systematic, process-oriented way of working. The ability to identify and develop solutions to quality and process problems. A pragmatic and adaptable mindset, with the ability to think beyond rigid or established approaches while respecting regulatory requirements. The ability to guide colleagues through processes by asking questions, highlighting considerations and ensuring required steps are completed. 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. Nice to have: Experience across multiple organisations or environments, providing exposure to different ways of working. Medical-device experience can be relevant but is not required. Experience with MDSAP How We Work At Vitestro, ownership is not a slogan - it is an expectation. We trust people to take responsibility, make decisions, and drive work forward. We believe breakthroughs happen when talented people combine dedication, accountability, and teamwork. That means: • We take initiative rather than wait for direction. • We focus on execution and delivering results. • We proactively remove blockers and help each other succeed. • We challenge ideas, not people. • We continuously learn, improve, and raise the bar. • We celebrate team success over individual heroics. We move fast, but we do so thoughtfully. We care deeply about quality because the technology we build ultimately impacts patients and healthcare professionals. If you are looking for an environment where you can make a significant contribution, take ownership of meaningful work, and be surrounded by highly motivated colleagues, we'd love to meet you. 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. Training budget Opportunity to be key shaper of a new global industry niche: autonomous medical robotics We’re big fans of working from the office – this is where team spirit comes alive. At the same time, we offer flexibility, allowing up to two (out of 5) days of working from home for those who prefer it. Are you excited? We totally understand that and so are we! By joining us, you can play an active role in changing the future of health care. Excited to join our revolution? Then we’d love to hear from you! If you think you've got what it takes, but you don't meet all the requirements - we still recommend you apply. We would love to learn about your interest and experience and consider if you can be a good fit for Vitestro. Nobody is a perfect fit, and we welcome applications with imperfections. We offer a learning environment where we grow together!