About Scanwell

Scanwell is a pioneer in instant, at-home lab testing. We were the first to receive FDA clearance for a home urine test to diagnose urinary tract infections. Since then we’ve developed tests for chronic kidney disease, malaria, and now, COVID-19. Scanwell provides clinical-grade testing, instant results, and professional guidance for comprehensive healthcare from the safety of people’s homes.

Position Summary

As our Quality System Engineer, you will make sure our products continue to be awesome and ensure regulatory compliance. You will help streamline our quality control process to improve workflow. You will become familiar with every part of our products and work closely with all regulatory, engineering, design.

Responsibilities:

  • Ensure regulatory compliance with FDA QSR, IEC 62304, ISO 14971
  • Ensure compliance with

Education:

  • Bachelor’s Degree

Experience:

  • 2+ years as a Software Quality Engineer
  • 1+ years working in an FDA/ISO regulated environment
  • 1+ years of experience helping with FDA/ISO software documentation

Knowledge and Skills

Required:

  • Hands-on experience working in issue tracking tools like Jira and Confluence
  • Hands-on experience with code management solutions like git
  • Experience writing code in at least one of the following: Python, Swift, Objective-C, Java, Kotlin, C, C++, Ruby
  • FDA QSR
  • IEC 62304
  • ISO 14971
  • Great communication and technical writing skills
  • Strong presentation skills to present test results to individuals and groups
  • Ability to work independently and as part of a team
  • Team player

Ideal:

  • ISO 13485

Scanwell Health is committed to having a workforce that is reflective of the diversity within the United States. As an equal opportunity employer, we encourage applications from candidates from underrepresented communities, Indigenous persons, persons with disabilities, persons of diverse sexual orientation and gender identity, and all those who can provide different perspectives and contribute to the diversification of Scanwell Health

  • Medical, Dental, and Vision
  • 401(k)
  • Stock options
  • Growth potential and opportunity to have a significant impact at an early stage company
  • Working with an incredible team that's trying to make the world a healthier place