Breas Medical was founded in Gothenburg, Sweden in 1991. Last year marked the 25th anniversary of providing innovative respiratory medical device products to the global market. Breas offers a complete and comprehensive line of respiratory medical devices from CPAP to Homecare Life Support Ventilation and everything in between. Breas successfully marketed the Vivo and iSleep product ranges, the Nippy and Clearway brands, and the Z1 CPAP range, redefining CPAP use in terms of size, weight, and portability.
Today Breas is a global company selling in more than 40 countries through our network of subsidiaries (Sweden, UK, Spain, Germany, USA) and highly specialized distributors.
At Breas we are passionate about improving the quality of life of patients by deploying organizational excellence in product development, customer service, manufacturing, sales, marketing, quality and regulatory affairs.
If you want to make a difference in the quality of life of respiratory patients, you are welcome to join Breas Medical as a Quality Engineer reporting to the site head of quality and regulatory. This position is based at our Sweden facility.
The purpose of this position is to Promote the awareness of regulatory, customer and statutory requirements throughout the organization. Support and develop an awareness of risk management, the development and implementation of the Quality Management Systems and maintaining its effectiveness. Participate or manage quality and regulatory reviews and quality investigations in QMS processes.
Essential Job Functions
- Support continuous product and process improvement
- Manage customer complaints and report adverse events to the regulatory authorities under the guidance of head of quality
- Conduct internal audits and assist in external quality management audits
- Maintain up-to-date knowledge and understanding of current regulatory requirements within area of responsibility
- Demonstrated understanding or aptitude to understand Medical Device QMS requirements and regulatory requirements (FDA 21CFR 820, ISO 13485, MDD, MDR)
- Demonstrated knowledge about Complaint and vigilance reporting especially for US, Canada and EEA
- Ability to communicate in Swedish and English
Education and/or Experience
- S. in Engineering, Engineering Technology, Science or minimum 4 years of experience in Medical device regulated industry
- Change agent with energy, passion and enthusiasm
- Energizing others by building a connection with the team through personal involvement and trust, providing feedback and coaching to help develop others
If you have any questions about this position please feel free to contact recruitment consultant Tom Bergqvist at +46 0733 – 87 27 22
You are welcome to send your application to: firstname.lastname@example.org as soon as possible but no later than 25 May.