Breas Medical was founded in 1991 in Mölnlycke, Sweden, as an entrepreneurial company that quickly developed to become one of the global leaders in home mechanical ventilation and sleep treatment. We successfully market 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 we are a global company selling in more than 40 countries through our network of subsidiaries (Sweden, UK, Spain, Germany, USA) and highly specialized distributors. Our 150 employees are the backbone of the company. We all share the same passion for patients and customers which shows in how we approach customer service, product development, manufacturing, sales, marketing, quality and service.
If you want to make a difference to home care patients, welcome to join us as our new QA Engineer.
We are now recruiting a Quality Assurance Engineer (QA Engineer) to strengthen our QA/RA-team.
As a QA Engineer you support continuous product and process improvement through detailed failure analysis for non- conformances and you investigate, develop and implement effective and compliant solutions for product or process corrections, retrospective and remediation action plans, and for corrective and preventive actions (CAPA Program).
Your key responsibilities
- Identify and report any quality or compliance concerns and take immediate corrective action as required.
- Preparing input data to CAPA review board and Quality management review.
- Coordinate the complaint team’s work
- Preparing and conducting hazardous trending and decision for actions needed
- Assisting in preparing input data for reportable events and FSCA
- Conduct internal audits and assist in external quality management audits
- Assisting in process or application validation activities
- Ensuring that documents comply with established templates, formats, and identification/naming/numbering standards.
- Maintain up-to-date knowledge and understanding of current regulatory requirements within area of responsibility
- Bachelor’s degree (or high school diploma/GED plus 4 years working experience in Quality Engineering or Quality Assurance Management in the medical device industry
- Demonstrated understanding or aptitude to understand Medical Device QMS requirements and regulatory requirements including but not limited to FDA 21CFR 820 and ISO 13485
- Demonstrated knowledge of Quality Management System tools, continuous improvement methodologies
- Demonstrated knowledge of CAPA requirements
- Demonstrated knowledge about Complaint and vigilance reporting especially for US, Canada and EEA
To be successful in this position you must be able to communicate efficiently in English. You have strong problem-solving skills and operate with ease in a cross-functional environment. You will be based in our Mölnlycke-based headquarter. You are reporting to our site QA/RA Manager.
Applications are handled continuously. We are looking forward to have your CV and a Cover Letter sent to email@example.com
If you have any questions please feel free to contact Tom Bergqvist at + 46 (0)733 – 87 27 22.