Portland, OR /
Hardware Engineering /
We are looking for a Quality Engineer to join our team!. This is a great opportunity to join an exciting, rapidly growing company with a highly collaborative and high-performing team. If you are a strong QE with a desire to work on connected IoT medical devices… this position could be for you.
Kinsa was founded with a mission to stop illness from spreading by knowing where and when it starts. Our mission has never been more important or more relevant than it is right now. We are leading the charge in the fight against COVID-19. Our real-time map of illness has been featured in the New York Times, on Rachel Maddow, CNBC, FOX News, The Economist, The Daily Show with Trevor Noah etc. Turn on the TV, open the paper… We are making headlines bringing our Data to the fight. We’ve done this by successfully transforming the first device you grab when sickness strikes - the thermometer - into a sensor to detect when and where illness is rising, and communicate with those who have just fallen ill.
We are looking for someone to help us take our quality system to the next level as we expand domestically and internationally. This a great opportunity to shine in your current area of expertise and expand your expertise to new areas including: international expansion, high volume IoT consumer class II medical devices and MDSAP and MDD certifications.
· Come up to speed with, and ultimately own our quality system. You'll drive everything from QMS training to CAPAs to complaint handling to internal audits and international expansion
· Help us expand internationally
· Own product quality -- You'll work cross functionally with our engineering/supply chain/NPI/PM teams, test labs, vendors, and more to make sure we continue to ship the highest quality products.
· You'll help us create test plans, you'll help execute those tests plans, and analyze the results.
· Conduct supplier audits both domestically and internationally
· Support documentation efforts for regulatory submissions
Experience and Qualifications
· 3 - 10+ years of experience in a QE role
· Deep familiarity with running and maintaining a quality system
· Familiarity with 21 CFR 820, ISO 13485, and MDSAP
· Working knowledge with PLM tools such as Arena
· User advocate with an appreciation for public health
· Excellent communication and social skills
· Upbeat, adaptable, positive attitude
· Basic hardware lab experience is a plus (i.e. comfortable around soldering irons, voltmeters, bench power supplies, etc.)
· Experience with project and bug tracking tools: Jira, Confluence, TestRail is a plus
· BS degree or equivalent relevant work experience
There are four key characteristics of our team that we hope are traits you have as well:
Be Passionate: The Kinsa team is driven towards a goal that is bigger than themselves, they have a real passion in working toward a solution for a widespread social issue. Our work is stimulating, meaningful and has purpose.
Be Committed:We are committed to our mission. We have a tremendous opportunity in front of us: to change the face of public health and save hundreds of thousands of lives in the process. We are committed to working hard, working smart, working together, and doing what it takes to make a difference. Our time is now.
Be Efficient: We are a startup, and we are proud of our work so far but there is a lot more work to be done. Moving fast is the result of good planning, decision making, and execution.
Be Inclusive: Solving one of the most important public health problems of our time requires a mix of perspectives and approaches, which is why diversity of age, gender identity, race, sexual orientation, physical ability, religious belief and ethnicity are all welcome and greatly valued at Kinsa. We are as proud of our differences as we are of our shared passion for stopping the spread of infectious illness, and are always looking for people with varied viewpoints, skill sets, backgrounds and experiences to realize our mission.