QA Specialist Medical Software

​Do you have experience in coordinating software engineering with medical device regulatory and quality management and a will to work in a company with passion for purpose?

JOIN THE JOURNEY!

We are looking to recruit an experienced QA specialist within medical software to join a great team working with important products. 

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.

JOB DESCRIPTION

As QA specialist, 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 be working side by side with software project manager(s), 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.
You will have a broad scope of responsibilities related to quality and regulatory compliance and be involved in implementing initiatives to drive continuous improvement.

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

YOUR COMPETENCIES & BACKGROUND

We are looking for you with a university degree in science or engineering and a minimum of 5 years of documented experience working in the regulatory environment of the Medical Device Industry with excellent knowledge of the regulations for design of Software as a Medical Device (SaMD). 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.

BEING 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!

In this recruitment we collaborate with our partner Poolia. Do not hesitate to contact Krishan Johansson Hague if you are curious about the role, 072-070 16 53.

krishan.johansson-haque@poolia.se

Looking forward to meet you!

Additional information

  • Remote status

    Flexible remote

Or, know someone who would be a perfect fit? Let them know!

Kista

Borgarfjordsgatan 18
164 40 Kista Directions PeopleandCulture@brighter.se +46(0)8-550 088 20 View page

Three reasons to join us.

  • Passion with purpose.

    Today millions of people live with chronic conditions. At Brighter you get the chance to be part of making their lives easier and improve health care globally. You get to go to work and make a change, every day, together with a passionate team. You might say that working at Brighter is more a lifestyle than a job, yet said with the insight that our work life balance is a key to success.

  • Focus on company culture.

    Diversity is a natural part of our culture and we dare to say that we are all talents. We speak broken English with team members from all over the world. We are passionate and proud about our products and services, which forms us to be ambitious teams organized in a non-hierarchical network organization with our slogan - “Team up - winning together”.

  • Tech and digital nerd? No worries, you are among friends!

    At Brighter we are really into tech and digital development, all our functions are driving digital transformation in the way they can. We aim to practice as we preach as Brighter is a data driven company where technology is our base. Our company roots are Swedish, as is our headquarter based in Kista, Stockholm. Upon that we have engaged teams in Dubai and Jakarta and more to come as we aim to improve health care globally!

We are human innovation.

We exist to improve people's quality of life.

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.

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