Quality Assurance Engineer/Specialist
Role summary
Pulmvita, a medical equipment company specializing in portable oxygen therapy, is seeking a Quality Assurance Engineer/Specialist for a full-time, remote/hybrid, 1-year contract role. The primary responsibility is to develop the company's quality management system (QMS) and lead regulatory submissions. This includes drafting SOPs, designing and documenting test cases, and ensuring software and systems meet quality and compliance standards. The role involves close collaboration with development teams to resolve issues and provide quality assessments. Experience in the medical device industry with knowledge of ISO 13485, Health Canada, and FDA regulations is required. Experience with respiratory medical devices and ISO 18562 is a plus.
Company Description
Pulmvita is an Edmonton-based medical equipment company on a mission to redefine portable oxygen therapy. Our flagship innovation, the PillowsPlus Nasal Cannula (PPNC), utilizes proprietary breath-detection technology to ensure patients receive a consistent, reliable flow of oxygen. With a recently secured raise and compelling clinical trial results, we are bringing the PPNC to market and expanding our portfolio of respiratory innovations.
Role Description
We are seeking a pivotal team member to develop our quality management system (QMS) and regulatory submissions as a Quality Assurance Specialist/Engineer. This is a full-time, remote/hybrid role with a 1-year contract (possibility for extension). In this role, you will draft SOPs, design and document test cases, and ensure all software and systems meet quality and compliance standards. You will work closely with development teams to identify and resolve issues, as well as provide detailed quality assessments for ongoing and completed work. You will work under the mentorship of an experienced Quality Manager.
Qualifications
- Proven experience in quality management within the medical device industry.
- Deep familiarity with ISO 13485, Health Canada, and FDA regulations.
- Experience with respiratory medical devices and ISO 18562 is an asset.
- Experience with QT9 and SolidWorks is an asset.
- Bachelor's degree in Engineering, Biotechnology, or a related field.
Compensation
$30-40/hr depending on experience level.
Start Date
Ideally by May 2026.
How to Apply
Please send your resume and cover letter to
info@pulmvita.com
or apply on LinkedIn.
*Note: candidates must be legally eligible to work in Canada.*