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Quality Analyst

by | Jan 12, 2021 | Careers | 0 comments

The Company

The Ventilator Project is a new non-profit startup located at MassRobotics in the Seaport district of Boston. Our mission to construct a low-cost, universally accessible ventilator that can 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.  

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.

JOB

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.

●  Ensuring compliance with current regulations.

●  Monitoring and reporting on all activities, processes, and procedures, noting any relevant
deviations from existing standards.

●  Determining data-driven solutions and implementing quality improvement plans.

●  Performing regular inspections and reviews to ensure employees adhere to quality and
safety policies and on products through the sampling process, production, and
post-production receipt

●  Assisting with the development of company policies, processes, and procedures.

●  Providing departments with quality planning, support, and training.

●  Preparing and maintaining quality management documentation.

●  Interface with our on-site QC team to schedule inspections and ensure that the inspection
process is handled accurately based on the product requirements.

●  Review and identify potential areas of failure or deviance to standard in our products and
areas for quality control improvement and implement new records accordingly.

●  Partner with factories to make sure that all testing protocols are adhered to and completed
on time and per the correct standards

●  Process all inbound product returns. Track return reasons, identifying areas of customer
dissatisfaction, regret, or defective product

REQUIRED SKILLS

REQUIRED SKILLS

  • ●  Hold a bachelor’s degree.
  • ●  Excellent communicator and strong interpersonal skills. You will be working in a
    multi-disciplinary team to achieve common goals.
  • ●  Worked in quality assurance or testing.
  • ●  Utilized any QMS system in a workspace.
  • ●  Attention to detail.
  • ●  This position is on-site only. Flexibility to work part-time as well as remotely but
    expected to be on-site at minimum a few times a week.
  • ●  Understand generally accepted analysis and design techniques.
  • ●  Experience documenting testing protocols.
  • ●  Excellent communication, interpersonal, and public speaking skills
  • ●  Excellent problem solving, decision making, and analytical skills

●  Excellent organizational and time management skills

●  Ability to be on-site
IDEAL SKILLS

●  Comfort in understanding and utilizing advanced biological and/or engineering terminology in both writing and speaking.

●  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
The team comes from a diverse set of backgrounds and skill sets, but each of us share a common calling: we couldn’t continue to sit and wait. We knew it was time to step up and find a solution.

Please Apply Here: https://k7y.pl/s/z2Xp6