QA/RA Specialist, Medical Technology!

One of the focus areas at i3tex is product development within the Medtech industry, where we get the opportunity to match our engineers' passion and technical expertise with customers that share the vision of a better world with the help of technology. We have for example been involved in the development of advanced wound care, respiratories, implants and much more.

Thanks to fantastic team efforts and customer deliveries, we have received both extended and new customer inquiries and are interested to further strengthen our Medtech-team within Quality and Regulatory in Gothenburg. In addition to customer assignments, we offer you the opportunity to be part of the development of our internal quality work within the Medtech area.

The work involves qualified advice and hands-on work within Quality Management Systems i.e. ISO13485, auditing, risk management, process validation, SW validation, performance evaluation, development process, CE-marking process MDD/MDR/IVDD/IVDR, technical documentation, compliance issues, training sessions etc. Our customers span from start-ups to large international companies.

We are looking for you who have / are:

- Very good knowledge in relevant Medtech standards and regulations and the ability to apply them in practice.
- Experience in project management, internally or at customer assignments.
- An eye for writing technical documentation according to applicable regulations.
- Your academic education could be engineering, science or similar.
- Good knowledge in Swedish and English, both orally and in writing.
- Previous experience in medical technology and product development is mandatory.


As a person you should be communicative, structured, used to take initatives and have an eye for details. You also need to be comfortable with communicating with authority across the organization, be willing to share your knowledge and to build strong relationships both internally and externally.

About us

i3tex is a value-driven technology consultant company and together with our customers, we develop products that simplify and enrich people's everyday lives in an innovative and sustainable way. i3tex consist of technical consultants who possess the drive and desire to do things differently and we share the ambition to make the world better through technical innovations and product development.

We believe in a strong business culture, to grow together and to have a lot of fun along the way! Today, we are 170 employees in six offices around Sweden. The customers are in Automotive, Medical Technology, IT & Digital Solutions, Aerospace and Industry. The three i:s in i3tex stands for innovate, implement and improve.

If you want to ask questions about the position or about i3tex as a company, you are welcome to contact Business unit manager Anna Axelsson and if you have union questions, you can contact one of our union representatives through 031-589700. We look forward to receiving your application!

Contact

Anna Axelsson 031-589717