200+ applicants

Company

Original Job Post

Verily · 5 days ago

Software Quality Engineer

Raleigh, NC

Full-time

Hybrid

Senior Level

$123K/yr - $189K/yr

5+ years exp

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H1B Sponsorship

Comp. & Benefits

Hiring Manager

Emma Brolan

Insider Connection @Verily

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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

Find out how your skills align with this job's requirements. If anything seems off, you can easily click on the tags to select or unselect skills to reflect your actual expertise.

FDA QSRISO SaMDIEC AAMI TIR45CollaborationProject ManagementTrainingDigital HealthHealth ITMobile Medical ApplicationsAI/MLRegulatory RequirementsSDLCQMSAgile/ScrumSoftware QMS ProcessesAgile MethodologyOrganizationalInterpersonalCommunication

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.

Founded in 2015

South San Francisco, California, USA

1,001-5,000 employees

https://verily.com

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)