- Kemi och bioteknik
- QA och testning
Ansök senast: 2021-11-20
QA/ RA Specialist, MedTech!
Product development within the MedTech industry is in focus at i3tex, where we get the opportunity to match our consultant’s passion and technical expertise with customers sharing the vision of a better world with the help of technology.
Thanks to a fantastic team effort and customer deliveries over the years, we have received both extended and new customer inquiries within MedTech and are interested to further strengthen our MedTech Team and particularly within Quality and Regulatory affairs. You will be a key player in our continuous growth and work together with a wide spectrum of customers, ranging from start-ups to large international companies. In this position would will have the opportunity to work in projects both inhouse at i3tex and at the customer sites.
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.
We are looking for you who have / are:
- Very good knowledge in relevant Medical Device Standards and Regulations and the ability to apply them in practice.
- Experience in project management.
- An eye for writing technical documentation according to applicable regulations.
- Academic degree in 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 initiatives 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.
i3tex is a technical consultancy company consisting of 170 creative people with different skills - everyone with a burning ambition to make the world a little better with the help of technology! We believe in the power and joy of sharing common goals with an opportunity to develop and grow as an individual. Our company culture is characterized by three values: Joy, Consideration and Ambition. We want it to be fun to work with us at i3tex, we treat each other with respect, we help each other succeed, we have high ambitions to always be driven forward, both as individuals, and as a company, and not least – we believe that everything is possible!
If you want to know more about the job position or i3tex, please contact Business Unit Manager Anna Axelsson. If you have questions regarding the labour unions, please contact one of our labour union representatives by 031-589700.
Welcome with your application!
Anna Axelsson, 0700-889705