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QA manager

Ensuring quality of our
medical device software

The Job

UgenTec is an international and fast-growing bioinformatics company specialized in the development of diagnostics software for PCR based DNA interpretation and analysis.

The UgenTec software solution is situated on the challenging crossroad between IT and biotechnology, directly aimed at laboratories and biotech companies in the market of clinical diagnostics. We’re on a mission to heavily disrupt the rules in this market and are already recognized with multiple awards that confirm the value and promise of that mission.

The UgenTec headquarters are located in Hasselt at the Corda Campus where a growing team of highly motivated talents is working on further bringing this promising solution to the global market. Moving quickly from a spin-off to startup to an international enterprise in the future, working for UgenTec will be both a challenging and a huge opportunity.

Function description

  • You know how to get people excited about QA and ensure a good implementation and operation of the quality management system.
  • You monitor all software development activities and ensure continuous improvement of the quality system, incl. audits and periodical quality reviews.
  • You detect risk from miles away and manage company-wide risk management activities
  • You manage quality-related challenges and ensure documentation is adequate yet lightweight for the team.
  • You continuously adapt the quality management system to changing regulations or client requirements
  • You know how to train people to understand quality & the implementation thereof
  • You ensure compliance to local legislation, guidelines and regulations
  • You are responsible for the submission of applications to obtain authorization for global marketing
  • You participate in and prepare for internal and external audits and inspections as required (notified body, FDA, competent authorities and customer audits)
  • You thoroughly know what a medical device is and can help clients regarding regulatory and legal requirements,
  • If necessary you will define and agree upon customer specific quality agreements and specifications
  • You organize and prepare management reviews
  • You ensure the promotion and awareness of regulatory and customer requirements throughout the organization
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The profile

You have about 3-5 years of experience in a similar position/ relevant environment and good knowledge of applicable ISO standards and regulations (ISO13485, IEN 62304, CE-IVD…) or related. If you have experience in scrum and/ or agile environments, that's a plus.

 

You hold a master’s degree in an IT-related field or a scientific domain or have equivalent experience. You have strong communication skills and are fluent in Dutch and English, verbally and written.


You like being in contact with customers and working closely together with people in different teams (sales, marketing, development...). You’re proactive and confident about your work
You aim to find solution-oriented in an organized and conscientious way. You're passionate about QA and self-motivating.

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The benefits

UgenTec stands for a stimulating startup atmosphere where you can grow your capabilities in an open and no-nonsense company culture. We want you to do the work you feel great at, or that you would like to become great at. We especially pay attention to keeping up our open communication even as we grow, with the natural desire to exchange views and ideas within our team.

 

We offer a fascinating role with continuous learning in an international environment where you will have the possibility to grow and shape a software solution right from the start. We combine state of the art data science with cutting edge technology in a streamlined development process to ensure we deliver only the best solutions to our customers.

 

 

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Applying is easy,
we review every
resume & cover letter

 

Apply here!