Junior Quality Assurance Officer at MRIguidance (3000€ - 4000€) at MRIguidance

Junior Quality Assurance Officer

Full time

€3,000 - €4,000

Vacancy: Junior Quality Assurance Officer
As a junior quality assurance officer you will contribute to the development and continuous improvement of the quality management system of a fast growing medical technology company. You will make sure that product design, development and delivery to hospitals worldwide takes place according to the latest regulations and guidelines. You will get many opportunities to learn on the job and follow courses to increase your value.

What you tell at birthdays about your job

“The company I work for makes radiation-free bone imaging accessible to you. Nowadays, if someone needs a bone scan, radiologists use an x-ray based CT scan which exposes the patient to harmful radiation. Our product, called BoneMRI, is a radiation-free alternative. It provides both bone and soft tissue information using only one machine and one exam. This prevents cancer, reduces patients' burden, and saves time and money for hospitals. My job is to make sure that the algorithms behind this innovative technique are developed according to the latest regulations and guidelines, making sure that our products keep improving and can be used in hospitals all around the world.”

What you actually will be doing

You will be a key contributor to the maintenance and continuous improvement to the quality management system and information security management system of MRIguidance. You will be part of a small quality assurance team and will report to the quality assurance manager. You will work closely with the development, clinical and management teams. You like to learn new things, share this knowledge within the team, and get things done. Your work will ensure our technology is compliant with all relevant regulations, and will help us to achieve high quality, clinical grade products.

Your responsibilities:

development, maintenance and improvement of the QMS and ISMS;
maintenance of the CE and FDA technical documentation;
perform periodic internal and external audits together with auditors from notified bodies;
monitoring and report root-cause analysis and implemented measures, in case of quality issues;
ensuring teams work according to the latest medical device regulations and guidelines.

Qualifications

Minimum qualifications:

a bachelor (HBO) degree in a relevant area such as law, life-sciences, engineering or another scientific discipline;
experience within quality assurance or regulatory compliance for medical devices;
demonstration of attention to detail, and the ability to consistently meet high standards required in compliance;
ability to speak and write in English fluently;
teamplayer.

Preferred qualifications:

experience with international standards for medical device software;
experience with product submissions under MDR/FDA;
experience with standards for information security management systems, such as ISO 27001;
problem solving attitude and skills;
ability to communicate and collaborate effectively with imaging researchers and clinical specialists;
the desire to work in a dynamic environment of a young and fast growing medical technology company.

About MRIguidance BV

MRIguidance is a medical imaging software company that develops and markets BoneMRI, the world's first imaging technique that visualizes all human tissues from one imaging exam, without the use of harmful radiation. MRIguidance’s BoneMRI software will improve diagnosis and is used for surgical planning and guidance. In July 2020, MRIguidance was selected as Europe's best-in-class innovation in healthcare by the European Institute of Innovation & Technology. BoneMRI is MDR CE certified for its use in Europe and since December 2021 it also has FDA clearance for marketing in the USA.

As a growing company, your personal development is stimulated such that your skills and capabilities grow with the needs of the company. We believe in the strength of a collaborative and open minded team motivated to seamlessly shape the future of medical imaging. We are a community of reliable and competent professionals with the drive to always improve ourselves, our work and our product. Everyone is encouraged to bring out the best in others and do their best for others because we really do care!

Our offer

This is what we offer you:

a full-time position;
a market conform salary, between 3000 and 4000 per month depending on your experience, with additional holiday and pension allowance, and optional bonus in shares;
an unique opportunity to, at an early stage, become part of a med-tech scale-up with vast growth potential;
work that has a positive impact on people’s health and life;
work in a team of smart and ambitious people;
work with international partners;
work in a startup/scaleup environment where you both get freedom and responsibility;
work at our beautiful office in Utrecht;

Additional information

We believe diversity is beneficial for the creativity and a good atmosphere of our company. However, Dutch regulation makes it very complicated for small companies to process a work visa for people from outside the EU . Therefore, all people are welcome to apply, as long as we do not have to arrange a work visa.

For more information about this position please contact David Sparks by email ([email protected]) or simply give us a call (+31 (0)85 4000 810).

To apply, please send a motivation letter and your CV to [email protected].

Application closes on November 25, 2022.

Acquisition regarding this vacancy is not appreciated.

How to apply

Application closes on November 25, 2022.