Do you have a thorough understanding of applicable medical device regulations and standards 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 an experienced QA specialist 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 [ Link removed ]
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!
As QA specialist you will have a key role in ensuring efficient implementation of Brighter’s quality management system processes. You will have a broad scope of responsibilities related to quality and regulatory compliance and be involved in implementing initiatives to drive continuous improvement.
You will function as a quality and regulatory ambassador in development teams and you will be working side by side with R&D project manager(s) to ensure efficient implementation of applicable quality and regulatory requirements (such as MDR,ISO 13485 and other relevant standards) throughout development and maintenance of Brighter’s medical devices to achieve and sustain compliance.
Brighter today consists of 55 people and you will be part of a global team based in Kista and you will report to the Head of QA/RA.
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 with medical devices controlled by ISO 13485 and of MDD/MDR. You have good knowledge of the regulations for design of medical technology products and experience of practical application of the requirements of relevant medical device regulations and standards. Professional fluency in Swedish and English is required.
• Experience in handling Complaints, Non-conformities, CAPAs, Incident reporting.
• Experience of practical application of ISO 14971 and an understanding of different tools for software risk management.
• Experience of practical application of IEC 62366, arranging and conducting/facilitating usability evaluations.
• Experience in software tools validation.
• Experience in performing regulatory activities such as writing Technical Files, review/approval of documentation for regulatory compliance.
• Experience in leading projects aimed at localization of user documentation and labelling to the requirements on the markets of interest.
• Strong technical communication skills.
• Experience as an ISO 13485 and/or ISO 27001 internal auditor.
• Experience in Clinical development applied to medical devices.
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 projects 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.
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!
Poolia Life Science