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QA Officer

Utrecht, Netherlands

Job description

Who we are 

Vitestro will be the first to bring autonomous blood drawing technology to European hospitals. Blood drawing, performed billions of times per year worldwide, is key to clinical diagnosis. Given the mounting shortages of healthcare personnel and global population growth, there is a clear need for a future-proof system to guarantee continuity of care.

 

To help solve this problem we are developing an autonomous blood drawing device. We are the first in the world to develop a fully autonomous blood-drawing device using a combination of state-of-the-art A.I. and robotics. The venipuncture device uses infrared and ultrasound to localize the vein in the arm of the patient. A robotic positioning system controls the interaction between the ultrasound probe and the arm of the patient, while an ultrasound probe creates a 3D image of the vein using artificial intelligence (A.I.). The optimal insertion location is determined by the software algorithms to position the robotic needle insertion in the middle of the vein, ensuring accurate and secure blood collection. The procedure is performed fully automatically, from tourniquet to bandage application.

 

We are ambitious and strongly believe that we have only just started. Technology lies at our core: multidisciplinary team primarily consists of highly specialized hardware and software engineers. We also have our own medical team, driving clinical trials together with our clinical partners. 


About the job

As QA Officer at Vitestro you will be responsible for all the Quality Assurance activities within the company. Vitestro recently obtained its ISO13485 certificate, providing you with a head start. Vitestro’s automated blood drawing technology is not yet on the market, but market launch is planned for 2024. 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 Head of QA/RA, you will be responsible for 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 be responsible for QMS audits, both internal as with our notified body. 

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.


If you also like Regulatory Affairs (RA) activities, there is enough room to work on both QA and RA topics. Together we will explore the different possibilities in the initial conversation.

Job requirements

What we are looking for

  • At least 3 years of experience in Quality Assurance (QA) for medical devices
  • Extensive experience with a Quality Management System (QMS) in line with the ISO13485
  • Experience with ISO9001 related to medical devices instead of ISO13485 is also acceptable
  • Experience with MDSAP is nice-to-have
  • Demonstrable achievements in bringing innovative MedTech products to the market and obtaining regulatory approvals
  • Excellent writing skills (English)
  • Excellent project management and project communication skills
  • Bachelor’s degree or higher, preferably technical background
  • Affinity with technology
  • Strong analytical skills, eye for detail
  • Nice to have: Medical Device Regulation (MDR, EU2017/745) knowledge and experience with building a technical file for MDR submission
  • Nice to have: Experience with IEC60601


What we offer

  • Competitive salary including pension plan
  • Stock option package, to become co-owner
  • An inspiring working environment
  • Work with driven and talented colleagues, that love to realize breakthroughs
  • Experience an open culture, where direct feedback is strongly encouraged
  • Focus on team play, including frequent out-of-work activities (such as ski-trips)
  • Daily lunches in the office

 

We need a go-getter who enjoys solving one of the toughest challenges. We are looking for someone who gets enthusiastic about reaching our goals as a team. A fit with our team values is important which are: Contribution to Patient care, Realizing breakthroughs, Team play, Ownership & Dedication, and Champions League (playing at the highest level).

For questions, please contact Mandla Malaba, mandla.malaba@vitestro.com.

For recruitment agencies – no thank you.


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