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Quality Assurance Officer

Posted 14 Jul 2024
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Work experience
3 to 4 years
Full-time / part-time
Full-time
Job function
Degree level
Required languages
English (Fluent)
Dutch (Fluent)

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Job description

Let's transform healthcare

At Vitestro, we will be the first to introduce autonomous blood drawing technology to European hospitals. Our team is growing rapidly. Do you have the pioneering mindset required to introduce this breakthrough innovation to patients? This is your opportunity to join us as Quality Assurance Officer.

Who we are

Staffing shortages in healthcare, aging population and rise in chronic diseases are huge problems that the health sector is currently facing. At Vitestro, it's our mission to improve patient care with our unique technology. And we're bloody serious about that!

By combining 3D ultrasound based on AI and precision robotics, our team created an autonomous blood drawing device. We are the first company in the world to introduce this innovation, that will revolutionize the healthcare industry.

Improving the lives of millions of patients runs through the veins of our business. Our extraordinary team of over 50 people loves to work on the toughest challenges to find cutting-edge solutions. We realize breakthroughs and change the future of health care. What's not to love about that?

Our can-do mentality and passion to work on the toughest challenges to find cutting-edge solutions leads us to a huge success: the product launch at the end of 2024. And for that, we need your help.

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.

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 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.

Job requirements

What you will bring

  • At least 3-5 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
  • Excellent writing skills (English)
  • Excellent project management and project communication skills
  • Bachelor’s degree or higher, preferably scientific background
  • Affinity with technology
  • Strong analytical and problem-solving skills, eye for detail

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.

Vitestro ontwikkelt een medisch roboticasysteem. Door 3D echografie te combineren met AI precissie robotica wordt autonome bloed afname verwezenlijkt. Dit systeem heeft de potentie een miljard patiënten te bereiken.

Engineering
Utrecht
Active in 1 country
48 employees
80% men - 20% women
Average age is 35 years