UgenTec is an international and fast-growing BIO-IT company specialized in the development of diagnostic software for PCR based DNA interpretation and analysis.
The UgenTec software solution is situated on the challenging crossroads between molecular diagnostics, informatics & data science. The product is directly aimed at laboratories and biotech companies in the market of clinical diagnostics. UgenTec is recognized with multiple awards that acknowledge their value of the delivered innovation. The UgenTec headquarters are in Hasselt at the Corda Campus. Today, a team of 25 people works to bring the PCR automation solution further to the global market. The UgenTec team is very diverse, consisting of people with a biomedical and technical background. Moving quickly from a startup and spin-off to a fast-growing international enterprise, working for UgenTec will be both a challenging and a huge opportunity.
- 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
- 3-5 years of experience in a similar position/ relevant environment.
- Good knowledge of applicable ISO standards and regulations (ISO13485, IEN 62304, CE-IVD…) or related
- Experience in scrum and/ or agile environments are a plus
- A master’s degree in an IT-related field or a scientific domain.
- You have strong communication skills
- You are fluent in Dutch and English, verbal and written
- You like to be in contact with customers and to work closely together with people in different areas (sales, marketing, development team...).
- You’re proactive and confident of your work
- Customer- and solution-oriented
- Organized and conscientious
- Passionate and self-motivating
UgenTec is breathing a stimulating startup atmosphere where you can grow your capabilities in an open and no-nonsense company culture. We especially pay attention to keeping up our open communication and the desire to exchange views and ideas within our motivated team in a context of mutual trust.
We offer a one-of-a-kind role with fast paced personal development possibilities in an international environment. We combine state of the art data science with cutting edge technology in a streamlined & quality-driven development process to ensure we deliver only the best solutions to our customers.
We offer highly-competitive salaries with a packet of fringe benefits, including a car of your choice.