Are you looking for a role in a company that makes a difference every day through its innovative products that provide better breathing and quality of life? We are looking for a QA Engineer located in our Global headquarter in Mölnlycke, Sweden.

Who we are

Our vision at Breas is to provide innovative solutions that enable people with chronic respiratory conditions to live life to the fullest.

About Breas

Breas Medical was founded in 1991 in Gothenburg, Sweden, Breas Medical has become one of the global leaders in Home Mechanical Ventilation, Airway Clearance and Sleep therapy. Our vision is to provide Better breathing and quality of life to respiratory patients around the world and to help patients transition from Hospital to Home. Breas is headquartered in Sweden and has subsidiaries in the UK, Germany, Spain, USA and China. Together with network of highly specialized distributors, we serve over 40 countries worldwide. The Breas brands Vivo, Nippy, Clearway and Z1 are widely recognized and appreciated for their performance, ease of use and attractive design. Breas has approximately 200 employees, 50 of which in the USA. Our focus is first and foremost on the patients and customers we serve. We highly value our relationships, never compromise on quality, continuously improve customer support and expand our clinical excellence program consisting of study days, webinars, educational videos, symposia and clinical research. We work closely together with key opinion leaders around the world to stay updated on the latest clinical insights. All Breas products are designed to fulfil our vision and to help patients transition from Hospital to Home. We strive to become a total solution provider offering a broad range of products, from smart CPAPs to Bi-levels, NIV ventilators, Life-Support ventilators and Airway Clearance devices. Add to that a growing range of Accessories and Cloud solutions.

What we are looking for

We are looking for a medical device QA Engineer in the Göteborg area of Sweden. If you love to improve processes and products, here is your chance to contribute to better breathing and quality of life for patients worldwide.

As a QA Engineer, you will join Breas Medical's global QA&RA team with members in Sweden, UK, US and China to ensure that Breas global Quality Management System (QMS) is effective. Your focus is safety, quality and regulatory compliance and to promote a strong quality culture. You will work closely with colleagues from all functions to lead and support with QA activities, both planned and unplanned.

You will use your project management, coaching and training skills to drive process and quality improvements involving our cloud-based QMS and our other global IT applications (JDE ERP, JIRA, Sharepoint 365 etc.).

You will also conduct some of the internal and supplier audits.

When nonconformities and urgent quality issues are found, you will support with structure and methods for investigations and CAPA plans.

We are certified to MDSAP, ISO 13848 and MDD/MDR, and you will be part of the core team to prepare and host the annual audits, as well as any unannounced audits.

As you will work with both international and local personnel, both Swedish and English are a must.

Experience you will bring

• Formal qualifications include an academic degree in science, medical, engineering or other relevant field, plus at least 5 year's relevant experience, preferably from medical devices or other regulated industries.
• You have experience of QMS, preferably ISO 13485 or MDSAP, at a minimum ISO 9001, and leading process improvements.
• You are very organized and can work independently to complete your tasks, and follow up that others deliver too. You have a hands-on, can-do attitude that will fit well with our informal, entrepreneurial and friendly culture. You get things done.
• You enjoy leading improvements and investigations.
• You have strong communication skills and can train people in all functions effectively.
• You have excellent documentation skills.