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QA specialist

Belgium, Vlaams Gewest, HasseltQuality team

Job description

Our mission

UgenTec is an international and fast-growing bio-IT company specialized in the development of diagnostic & workflow software for molecular laboratories. The UgenTec software solutions are situated on the challenging crossroad between IT, data science and biotechnology. We’re on a mission to heavily disrupt the rules in our 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 diverse team of 50 people is bringing our SaaS software suite to the global market.

What you'll do

As QA specialist at UgenTec, you work closely with the QA manager to ensure the implementation, maintenance and continuous improvement of the UgenTec integrated management system in order to keep our ISO13485 certification. Together with the quality and regulatory team, you build a company culture in which product quality and innovation is all part of the UgenTec DNA. You are able to get people excited about QA and to motivate them for a decent implementation and operation of our integrated management system.

  • With support of the QA manager, you are responsible to review technical documentation of all product development activities to ensure compliance with the integrated management system.
  • You participate in risk management activities and keep documents updated.
  • You keep an eye on the timely execution of quality activities within the organization, you coach colleagues for quality & regulatory compliance.
  • You participate in the implementation and follow-up of non-conformities and corrective & preventive actions.
  • As process owner of particular quality processes, you are responsible to keep these procedures and processes adequate, efficient and Agile so they are easy to implement and maintain throughout the organization.
  • You train people to understand the UgenTec integrated management system & the implementation thereof.
  • You are responsible to keep the QMS tool up to date with regard to training records, procedures, audit reports, and other quality records.
  • Together with the QA manager you participate in and support internal and external audits and inspections as required (notified body, FDA, competent authorities, and customer audits).
  • You collaborate across teams and make sure quality is part of the daily operations.

Job requirements

What you’ll bring to the team

  • You have at least a bachelor degree in a (bio)medical, scientific or engineering background.

  • You have experience in working in quality environments, preferably in the medical device sector or clinical laboratories.

  • You are accurate and have an eye for detail. Quality is part of your DNA.

  • You are able to maintain an overview of the daily quality activities and able to set priorities.

  • You love to be part of a young, dynamic & agile organization, with enormous ambitions to change the market.

  • You take ownership of tasks and processes, think proactively about improving product safety and quality in a pragmatic way.

  • You have strong communicating skills, have a helpful positive mindset, and thrive in a casual yet professional atmosphere.

  • You are fluent in Dutch and English.

Our offer

UgenTec stands for a stimulating scale-up 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 combine cutting edge technology with a streamlined product process to ensure we deliver only the best solutions to our customers. If you feel like this could be the next big thing for you, make sure you’re not going to miss out and come over to have a chat with us.

We offer competitive salaries including

  • a car + fuel card (or mobility budget)
  • meal + eco vouchers 
  • mobile subscription
  • hospitalization insurance
  • 32 days off 

You’ll work from our headquarters in Hasselt, Belgium, with an option to work from home for 3 days a week.