Verily · 6 days ago
Software Quality Engineer
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Responsibilities
Participate in implementing Software Quality Management System in compliance with FDA and ISO standards.
Support software development teams in creating Design History Files and risk management activities.
Guide teams in design controls, risk management, and compliance to quality system.
Provide training and support for software Quality Management System and SDLC framework.
Qualification
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Required
BA/BS degree in Computer Science, Software Engineering, Informatics, Biomedical, related technical field or equivalent practical experience
5 years of experience in software design assurance in the FDA QSR/ISO 13485 medical device industry, primarily working on Software as Medical Device (SaMD)
Experience with the application of IEC 62304 (Medical Device Software Lifecycle Processes), AAMI TIR45, ISO 14971 (Risk management) and IEC 62366 Usability Engineering
Experience in project management, training, and working collaboratively with software development teams
Preferred
Experience with digital health, Health IT or mobile medical applications
Experience working on AI/ML-enabled medical device products
Experience working with novel technologies in a lean, fast-paced and highly innovative environment
Working knowledge of the application of regulatory requirements for wellness, low-risk and high-risk software applications using a scalable approach to the SDLC practices and the QMS
Demonstrated ability to implement and improve Software QMS processes using SDLC best practices, tools and agile/scrum/iterative methodology
Excellent organizational, interpersonal and verbal and written communication skills, with the ability to deliver quality outputs under minimal supervision
Benefits
Flexibility
Resources
Competitive benefits
Company
Verily
Verily is an Alphabet health tech company focused on research, care, and health financing to deliver on the promise of precision health. It is a sub-organization of Alphabet.
H1B Sponsorship
Verily has a track record of offering H1B sponsorships. Please note that this does not
guarantee sponsorship for this specific role. Below presents additional info for your
reference. (Data Powered by US Department of Labor)
Distribution of Different Job Fields Receiving Sponsorship
Trends of Total Sponsorships
2023 (54)
2022 (107)
2021 (99)
2020 (61)
Funding
Current Stage
Late StageTotal Funding
$3.5BKey Investors
Swiss Re Corporate SolutionsSilver LakeTemasek Holdings
2022-09-28Secondary Market· Undisclosed
2022-09-09Corporate Round· $1B
2020-12-17Series Unknown· $700M
Recent News
Business Journals
2024-04-30
Company data provided by crunchbase