- 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.
You can apply here