Quality Assurance Engineer for Regulated Medical Devices
1 week ago
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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