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Euformatics
As a Quality Manager, you will play an integral role in the success of Euformatics, helping to define and document key processes necessary for quality management systems such as ISO 13485. High operational quality of our product development and commercial activities is essential for delivering a safe and efficient clinical diagnostics tool for hospitals and laboratories analyzing patient samples.
You will act as a crucial gatekeeper between our customers and the development team, ensuring that the releases we deliver have been tested thoroughly and the testing has been documented according to the QMS. Hands-on software testing for the releases is part of the job so you will get to eat your own dog food. You will also participate to client projects as a quality representative to keep everyone in check what comes to regulatory requirements for clinical NGS test development, validation and verification. You will interpret what IVDR requirements mean in the context of genetic testing and translate that into product features and process descriptions both for our internal R&D and joint projects we have with our customers and partners.
Your pedagogic skills allow you to transfer knowledge efficiently to the development team about the existing and new requirements that international quality standards and EU regulation for IVD devices bring. Our team will trust you to guide them to the right direction when it comes to day-to-day documentation of our activities.
The following is what we consider essential for this position:
What we would consider a bonus:
The chance to make a real impact on the way diseases are treated. As a small company, we are a tight-knit, supportive group of specialists who all share the same mission and purpose. We offer an environment to freely share your ideas, brainstorm and give you the opportunity to make your own dent in the universe.
We are flexible in our working hours, as long as the work gets done. We do not expect you to work late into the night – this is Finland after all, not the USA. As a truly international workplace (we speak 12 languages fluently), there is always a lot of energy bouncing about.
We are working at the forefront of technological and regulatory change in a field which is already affecting the way we live. This is your chance to play a pivotal role in helping to drive that change and have a truly global impact on the way that clinical genetics is performed.
We play the infinite game here at Euformatics. And occasionally some ping pong as well. In order to succeed in a complex and difficult field we need to work with people that commit to our mission and are in this for the long term. We are looking for people that want to make a difference and have the drive to make a long-lasting change. If this resonates with your ambition, please get it touch. We would love to hear from you!
Send a short email to tommi.kaasalainen@euformatics.com and let us know you want to talk!
Please attach your CV and tailored cover letter for the position.
This position will be filled as soon as a suitable candidate is found!
