Quality Assurance Engineer for Regulated Medical Devices

1 week ago


Mississauga, Ontario, Canada Vitalbio Full time
Job Description

Vitalbio is a leading provider of innovative medical devices, and we're seeking a highly skilled Quality Assurance Engineer to join our team.

About the Role:

  • We're looking for an experienced Quality Assurance Engineer to ensure the highest standards of quality in our software products.
  • You will design and execute test strategies, both automated and manual, to identify issues early and improve our quality processes.
  • You'll be responsible for managing documentation and tracking to ensure comprehensive records of test results, defects, and resolutions.
  • You will work closely with our QA team to develop and review validation plans and provide guidance on regulatory requirements.

Requirements:

  • Experience in the software quality assurance of regulated medical devices.
  • Knowledge of and experience working in a quality system conforming to FDA 21 CFR part 820, ISO 13485, and ISO 62304.
  • Experience using issue tracking tools, such as Jira.
  • Familiarity reviewing code with an eye to verifiability.
  • Familiarity with reviewing and reasoning about automated verifications such as unit automated tests and functional automated tests.
  • Strong understanding of key QMS processes like Design Control, Document Control, Change Control, etc.
  • Good communication skills and the desire to collaborate with a team of good-natured professionals in a variety of disciplines.
  • An understanding of the Software Development Lifecycle (SDLC), both as described by standards and in practice.

What We Offer:

  • A competitive salary of $120,000 - $150,000 per year, depending on experience.
  • A dynamic and supportive work environment.
  • The opportunity to work on cutting-edge medical devices.
  • A comprehensive benefits package.


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