Quality Systems Engineer
Scanwell Health makes healthcare more accessible through smartphone-enabled, at-home diagnostics. Scanwell's innovative approach lets people test from anywhere, skip the waiting room and get same-day results. By quickly diagnosing acute illnesses, chronic diseases, and rare conditions, Scanwell accelerates the path to treatment. Our first product is the only FDA-cleared over-the-counter app that provides testing and treatment for urinary tract infections (UTIs).
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 List 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 building software that turns your smartphone into a medical testing lab. The core of our business is developing custom computer vision algorithms using OpenCV to make scanning your medical test as easy as taking a picture. Our backend application is built with Rails and hosted on Aptible. We leverage GCP offerings such as Colab, Firestore, and Cloud Functions for internal research, and we want to expand this into a world-class research platform one day.