All opportunities with TVP Health are currently unpaid volunteer positions that will give you a rich and unique opportunity to learn and participate alongside highly regarded industry experts.
TVP Health is a 501c3 nonprofit located at MassRobotics in the Seaport district of Boston. Our mission to simplify complex biomedical products to make them accessible and affordable for all. Our first ventilator, AIRA, was developed to be a universally accessible ventilator that could save the lives of Covid-19 patients experiencing respiratory illnesses worldwide. Current ventilators can cost upwards of $40,000. Our goal is to rapidly prototype, build & ship ventilators built from readily available parts for a fraction of this price, providing hospitals & patients with a cheaper alternative. Everyone deserves a chance to fight COVID19, fight with us. As of March 2021, our AIRA ventilator acquired the FDA EUA (Emergency Use Authorization).
DISCLOSURE: Current on-site volunteers are working in an isolated office setting while practicing safe social distancing practices. We have gloves and masks readily available, and the office space is professionally cleaned several times throughout the week.
The Ventilator Project is looking for a quality analyst who will be responsible for taking initiative and setting goals with the quality team for the establishment and development of a QMS system. This includes creating templates, requirements, and FMEA documents to create a successful FDA EUA execution. Also, they will implement and monitor test scripts to assess functionality, reliability, performance, and quality of the ventilator. This includes the responsibilities of inspecting processes, and our product, ensuring compliance with new and existing quality standards and regulations, implementing quality management actions, and contributing to the development of company policies and procedures.
- Hold a bachelor’s degree.
- Worked in quality assurance or testing.
- Utilized any QMS system in a workspace.
- Familiar with Good documentation practices.
- Understand generally accepted analysis and design techniques.
- Experience documenting testing protocols.
- Excellent communication, interpersonal, and public speaking skills
- This position is remote or on-site and unpaid/volunteer. Analysts are expected to work a minimum of 4 days per week, ~3 hours per day.
- Comfortable in understanding and utilizing advanced biological and/or engineering terminology.
- Relevant background in a scientific or engineering field
- Lean Six Sigma/A3 experience.
- Familiarity with international standard documents is a plus.
- Demonstrated experience in defining test plans and strategies and executing testing processes.
- 2+ years of experience working with quality systems in a regulated industry
Please Apply Here: https://k7y.pl/s/z2Xp6