QA Manager Medical Software to Brighter AB

Do you have experience in coordinating software engineering with medical device regulatory and quality management and a will to work at a company with a strong culture where we team up and win together? Brighter AB (publ.) is now looking to recruit a QA Manager within medical software to join a great team working with important products. Join the journey!

Brighter is a health-tech company from Sweden with a vision of a world where managing chronic diseases is no longer a struggle. We believe a data-centric approach is key to provide smarter care for chronic conditions. Our daily-care solutions facilitate the flow of real-life treatment data between chronic-disease patients, their loved ones and their care providers – improving quality of life, easing the burden on healthcare systems, and opening new opportunities for data-driven research. In 2019 the company won the Swecare Rising Stars Award. For more information visit https://brighter.se/
You will be working with Actiste devices and services that are designed for daily diabetes management, with smart features aimed at helping to keep your blood glucose under control.

Apply today as selection is ongoing and will interview candidates continuously.

We look forward to receiving your application!


About the position
As QA manager, you will function as a quality and regulatory ambassador in software development teams and coordinate the worlds of software engineering and medical device regulatory and quality management. You will have a broad scope of responsibilities related to quality and regulatory compliance and be involved in implementing initiatives to drive continuous improvement.

Main responsibilities include:
- Ensure efficient implementation of applicable quality and regulatory requirements (such as MDR, GDPR, IEC 62304, ISO 13485 and relevant internal procedures) throughout development and maintenance of Brighter’s medical device software to achieve and sustain compliance.
- Set up and maintain technical files for software products
- Quality Assurance support in the team (trainings, reviews etc) in developing and execution of product releases
- Support in developing and maintaining software specific processes in the Quality Management System.
- Work side by side with software project manager(s),

The position reports to the QA/RA lead at the company and you will be part of a global team based in Brighters headquarter in Kista.



Your profile
The right candidate for this position has following qualifications:
- University degree in science or engineering
- Multiple years of documented experience working in the Medical Device Industry with knowledge of the regulations for design of Software as a Medical Device (SaMD) either as a QA or as a software developer.
- Experience in software development, preferably in an Agile environment and a strong background in Design Controls as well as experience of practical application of the requirements of the IEC 62304 and ”how-to” make high quality software in a regulated environment .

You have good strong technical communication skills, able to write and speak to different audiences in appropriate language, able to articulate the importance of quality processes in language that engineers can understand. Professional fluency in Swedish and English is required.

To fit in with us and to succeed in this role, you have a genuine interest in medtech, as a person you are reliable, have a high sense of responsibility and strong interpersonal skills. You have a structured and organized way of working and can handle multiple tasks independently as well as manage priorities in order to meet project timelines. It is important that you have a can-do attitude and the ability to creatively solve problems and to go the extra mile in order to succeed.


About the organisation
BE A BRIGHTERIAN

At Brighter we have a genuine interest in driving change, our mission is to improve the quality of life of millions of people's. That goes for our teams as well. Our values are Smart, Friendly and Reliable and that is the guiding star for our attitudes and behaviors. How we lead ourselves and work together sets our company culture, and we thrive on having a company culture where we team up and win together. For us it's important that you are a team player and want to contribute to improving the world and Brighter's future success!