Senior Quality Assurance Officer

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. We are now expanding our Commercial organization to ensure successful growth and long-term success.

At Vitestro we are committed to continuous innovation and improvement.

Our can-do mentality and passion to work on the toughest challenges to find cutting-edge solutions leads us to a huge success: we are growing fast. And for that we need your help.

Senior Quality Assurance Officer

As a QA Officer at Vitestro you will play a crucial role in ensuring compliance with all applicable laws regulations and standards within the operations and product development focusing on Medical Devices manufacturing.

Your timing is perfect: you will be joining Vitestro during a highly interesting period as the next 12 months will be incredibly important from a quality and regulatory perspective.

Together with our QA/RA team you will support the maintenance of the QMS by making sure that the whole organization follows the Standard Operating Procedures (SOPs). When you think the SOP can be improved you will proactively suggest changes to the SOPs. Additionally you will offer support during QMS audits both internal as with our notified boy.

For this role you should have the right project management and communication skills to distribute the workload across the organization. You will play a key role regarding quality in the organization. You will perform a wide range of activities for example: risk management activities design & development topics production control employee training CAPA management supplier control etc.

What you will bring

• Minimum 3 to 5 years experience in Quality Assurance for medical devices preferably in a hardware-software environment

• Strong experience working within an ISO13485 Quality Management System

• Hands-on experience with verification and validation activities including writingand executing test protocols

• Experience with validation of production workflows

• Experience with MDSAP is nice-to-have

• Experience with equipment and process qualification activities (IQ OQ PQ)

• Familiarity with software validation or automated testing is an advantage

• Strong technical writing skills for test protocols validation reports CAPA documentation and engineering change records

• Strong analytical mindset with the ability to interpret test results assess failures and propose corrective actions

• Strong project management skills especially coordinating validation activities across engineering production and suppliers

• Comfortable working with engineering drawings CAD files and technical documentation

• Bachelors degree or higher in engineering applied sciences biomedical engineering or similar technical field

What we offer

• Competitive salary including pension plan

• 25 days of annual leave based on a full-time position

• Stock options to become co-owner of a fast-growing company

• Hybrid work model

• Working together in a high-skilled team with our home base in Utrecht

• Frequent out-of-work activities with our team (such as our Skitestro ski-trip)

• Training budget

• 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.

Are you excited

We totally understand that 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 wed love to hear from you!

If you think youve got what it takes but you dont 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!

For questions please contact Esther Crena Uiterwijk

For recruitment agencies no thank you