Tandem Diabetes Care · 5 hours ago
Sr. Software Quality Assurance Engineer I
San Diego, CA
Full-time
Remote
Senior Level
$95K/yr - $120K/yr
5+ years exp
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Responsibilities
Serves as a Quality representative on project core teams. Provides quality guidance throughout software development and maintains all quality-related deliverables.
Ensures quality integration into the overall functions of software development, scientific computation, and data acquisition.
Review/Approve various software lifecycle project deliverables based on procedural requirements.
Performs risk analysis and is responsible for risk management activities. Identifies, evaluates, and documents product risks. Coordinates risk-related updates with risk management team.
Provides traceability analysis and reports to ensure project requirements have been met
Participates on the Software Review Board (SRB) and Extended Software Review Board (ESRB) to evaluate and disposition software issues and Unresolved Anomalies.
Analyzes test results to ensure existing functionality and requirements are met, and if necessary, recommends corrective action.
Embraces the Design Control process by participating in design reviews and maintaining design history files.
Provides quality support and guidance for audits.
Qualification
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Required
Requires a bachelor's degree in Engineering or Computer Sciences or related field or equivalent combination of education and years of applicable experience.
5 plus years’ experience serving as a Quality representative on project core teams in an FDA-regulated industry, including experience with conceptual design to market release.
Has working knowledge of FDA and international regulations, e.g. QSRs, ISO 14971, ISO 13485, IEC 62304.
Familiar with Good Documentation Practices (GDP).
Excellent written and verbal communication skills.
Skilled at promoting team cooperation and a commitment to team success.
Adept at seeing change as an opportunity to improve business performance and campaigning for it when necessary.
Preferred
Knowledge of cloud or software-as-a-service (SAAS) strongly preferred.
Benefits
Health care benefits such as medical, dental, vision, health savings accounts and flexible saving accounts
11 paid holidays per year
A minimum of 20 days of paid time off (accrual starts on day 1)
Access to a 401k plan with company match
Company
Tandem Diabetes Care
Tandem Diabetes Care, Inc., a global insulin delivery and diabetes technology company based in San Diego, California, creates new possibilities for people living with diabetes, their loved ones, and healthcare providers through a positively different experience.
1,001-5,000 employees
H1B Sponsorship
Tandem Diabetes Care 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
Represents job field similar to this job
Trends of Total Sponsorships
2023 (6)
2022 (11)
2021 (6)
2020 (4)
Funding
Current Stage
Late StageLeadership Team
David Berger
EVP and Chief Operating Officer
Brian Hansen
Executive Vice President and Chief Commercial Officer
Recent News
The Motley Fool
2024-02-23
Medical Product Outsourcing
2024-02-02
Company data provided by crunchbase
