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About Prolira B.V.
Prolira is a medical device start-up, a spin-off of the University Medical Center Utrecht (The Netherlands). Our device has its roots in landmark clinical research led by neurologist-intensivist Prof. Dr. Arjen Slooter and his brain at risk group. The company was raised by Rutger van Merkerk and Annemarie Willems in 2015. We are backed by professional venture capital firms as well as business angels with experience of the field.
Prolira is hiring a Quality Officer
You will contribute to the development and continuous improvement of the quality management system (QMS) of the growing medical technology company Prolira. You will make sure that product development and delivery to hospitals takes place according to the latest regulations and guidelines. You will get many possibilities to be trained on the job and follow courses to increase your knowledge. We work closely in a network of Utrecht based medical technology start-ups, through which we share our QA knowledge, documents, and people.
What you tell at birthdays about your job
“I work at a very promising medical technology company. We ensure that brain activity measurements can be used by nurses at the bedside to adequately treat a serious complication called delirium. We improve healthcare and save lives.”
What you actually will be doing
Prolira and the companies in the network are all developing, improving, and certifying their ISO13485 QMS and are working on CE certification of their medical (software) devices. You will primarily work at Prolira, but since multiple teams in close vicinity of each other go through similar processes, the companies work closely together. As a QA Officer you will help with the implementation and improvement of the QMS and the technical file for CE certification and also for the FDA (USA).
- maintenance and improvement of quality systems and CE technical files;
- ensure all teams work according to the latest medical device regulations;
- keep adequate administration;
- work with experienced QA/RA consultants;
- work with auditors and other people from notified bodies and regulatory authorities.
- Life Science or technical graduate (University level or equivalent);
- ambition and capability to grow towards senior level;
- knowledge of ISO 13485 and regulatory landscape;
- ability to speak and write in English fluently.
- experience in Quality Management of Medical Devices
- experience with medical hardware and software;
- problem solving attitude and skills;
- easy learner;
- ability to communicate and collaborate effectively with researchers and clinical specialists;
- the desire to work in a dynamic start-up environment.
Prolira is a medical device start-up, a spin-off of the University Medical Center Utrecht. Our device has its roots in landmark clinical research led by neurologist-intensivist Prof. Dr. Arjen Slooter. The company was raised by Rutger van Merkerk and Annemarie Willems in 2015. We are backed by professional venture capital firms as well as business angels with experience of the field. In 2019, we will implement our solution in routine practice of our many clinical partners and customers. Prolira has its office at the dynamic environment of business incubator UtrechtInc at Utrecht Science Park.
- a salary which is compatible with market standards ;
- 0.6 FTE job, with the potential to grow to full-time;
- a unique opportunity to, already at an early stage, become part of not one, but multiple med-tech companies with significant growth potential;
- work that has a positive impact on people’s health and life;
- work in a team of smart, ambitious, and like-minded people;
- work with and learn from experiences QA consultants;
- the ability to learn on the job and improve your knowledge and skills with relevant trainings;
- freedom and responsibility;
- work in inspiring environments.
For more information about this position please contact Rutger van Merkerk by email (firstname.lastname@example.org) or simply give us a call (+31 6 4776 2936). To apply, please send a motivation letter and your CV. Application closes December 20th, 2018.
3584 CH Utrecht
tel: +31 (0)6 2297 8972