Software Quality Engineer
Vital Bio
This job is no longer accepting applications
See open jobs at Vital Bio.See open jobs similar to "Software Quality Engineer" TELUS.We are Vital. We build products that combine cutting-edge science and intuitive design in ways that make measuring health and taking action accessible by everyone. Our mission is to democratize technology that puts people in control of their health.
The software engineering team at Vital is seeking an experienced and diligent software quality engineer to join our effort to bring our cutting-edge in-vitro diagnostic analysis platform to the market.
What you'll do:
Bring your experience in software quality to help craft and formalize our software development procedures and plans.
Establish those procedures and plans by implementing, training, and maintaining them.
Participate in reviews of software system requirements, specifications, verification plans, design trace, etc. as a software quality SME.
Train others on following software quality system processes and mentor them on the quality focused mindset.
Suggest and implement improvements to the software quality system to make it more effective and less burdensome.
Assist in software-related risk management activities and establish traceability between identified risks, mitigations, verifications and validations, and requirements.
Support internal and external audit of the software quality system and its records.
Adhere to and contribute to Vital's QMS policies, SOPs, etc. to ensure in-vitro diagnostic standards and regulations for the US, CA, and EU are met.
Actively participate in the design and development process, verification and validation activities of new product development lifecycles.
What you’ll need:
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 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.
Bonus points for:
ASQ CSQE certification.
Prior experience with conducting and supporting audits, internal and external.
Familiarity with a variety of software development approaches from low formality to full formality.
Familiarity with Rust, Python, or Nix.
Knowledgeable about FDA regulations and requirements associated with medical device cybersecurity concerns, quality processes, and deliverables.
Experience with compile-time safety and leveraging static analysis for software quality.
Experience with networking and network protocols: TCP/IP, HTTP, JSON.
Strong prior experience with software risk management.
Familiarity with laboratory environments and in-vitro diagnostics.
Appreciation of puns!
About our team:
At Vital, we thrive on change, operate on trust, and leverage the diversity of perspectives from a global team in everything we do. We operate at a rapid pace and we push key decisions to folks on the front lines across the organization. Our culture is fundamentally rooted in having a growth mindset - which means at Vital you will make an impact; your talent and energy will make a difference, and your life’s best work will be possible. As a workplace, we challenge and support you to hone your craft and be a part of something bigger than any of us.
This job is no longer accepting applications
See open jobs at Vital Bio.See open jobs similar to "Software Quality Engineer" TELUS.