{"schemaVersion":"jobsearcher.job.v1","id":"dfca193ea373a5b2f2649015","url":"https://jobsearcher.com/jobs/dfca193ea373a5b2f2649015","canonicalUrl":"https://jobsearcher.com/jobs/dfca193ea373a5b2f2649015","title":"Sr. Software Quality Engineer","description":"*Job title : Sr. Software Quality Engineer*\n\n*Client : Medical Device Manufacturing Company*\n\n*Duration : 12 months + possible extension*\n\n*Location : Northridge, CA*\n\n*Schedule : 1st Shift | New Haven site | 4 days/week onsite*\n\n*Key Responsibilities*\n\n* Drive software quality for digital health solutions including iOS/Android mobile apps, AWS/IBM Watson cloud, data reporting, AI/ML.\n* Develop and execute quality strategies with R&D, Regulatory, Marketing, and Operations teams.\n* Drive quality throughout the SDLC using Agile, Waterfall, SAFe, and DevOps.\n* Define/review requirements, design, verification & validation (V&V), test plans, and traceability.\n* Participate in design reviews and approve requirements, design documents, code reviews, test results, V&V reports, and defects.\n* Lead software risk management, system risk analysis, and Software FMEA.\n* Lead CAPA projects and support internal/external regulatory audits and inspections.\n* Drive compliance with ISO 13485, IEC 62304, ISO 14971, HIPAA, FDA, Security & Data Privacy requirements.\n* Establish and maintain software quality processes, procedures, metrics, documentation, and controls.\n* Evaluate software requirements, design, development, integration, testing, verification, and validation.\n* Ensure traceability, testability, documentation, and process compliance.\n\n*Minimum Qualifications*\n\n* Bachelor’s degree in Engineering, Science, or Technical field + 4+ years Engineering/Software Development/Quality experience.\n* OR Advanced degree in Engineering, Science, or Technical field + 2+ years relevant experience.\n\n*Nice to Have*\n\n* Software design, development, V&V, and testing experience.\n* Embedded software/mobile apps: Java, Objective-C, Kotlin, Swift.\n* Cloud: AWS, Azure, IBM Watson.\n* ALM/Defect/Development/Test/CI-CD: PTC Integrity, Atlassian, TFS, Jira, Git, GitLab, Android Studio, Selenium, JUnit, Jenkins.\n* Medical device standards: ISO 13485, IEC 62304, ISO 14971, HIPAA, FDA, Security/Data Privacy.\n* AI/ML, data-driven solutions, wireless/Bluetooth, n-tier architecture, ITIL.\n* Digital health systems and Apple/Android products.\n* Certifications: Scrum Master, SAFe, Black Belt, Green Belt, or CQE.\n\n*Must-Have Technical Skills*\n\nISO 62304 | ISO 14971 | Risk Management | New Product Development | Defect Management | Software V&V | Agile Methodology\n\nIND\\_ENG\n\nPay: $50.00 - $55.00 per hour\n\nExpected hours: 40.0 per week\n\nExperience:\n* Software development: 4 years (Preferred)\n* relevant: 2 years (Preferred)\n\nWork Location: In person","company":"Three Point Solutions","rawCompany":"three point solutions","city":"Northridge","state":"CA","isRemote":false,"isActive":false,"createdAt":"2026-09-02T10:43:44.157Z","occupations":[{"code":"15-1252.00","title":"Software Developers","slug":"software-developers"},{"code":"15-1253.00","title":"Software Quality Assurance Analysts and Testers","slug":"software-quality-assurance-analysts-and-testers"},{"code":"17-2112.02","title":"Validation Engineers","slug":"validation-engineers"}],"industries":[{"code":"541511","title":"Custom Computer Programming Services","slug":"custom-computer-programming-services"},{"code":"513210","title":"Software Publishers","slug":"software-publishers"},{"code":"541512","title":"Computer Systems Design Services","slug":"computer-systems-design-services"}],"jobPosting":{"@context":"https://schema.org","@type":"JobPosting","title":"Sr. Software Quality Engineer","description":"*Job title : Sr. Software Quality Engineer*\n\n*Client : Medical Device Manufacturing Company*\n\n*Duration : 12 months + possible extension*\n\n*Location : Northridge, CA*\n\n*Schedule : 1st Shift | New Haven site | 4 days/week onsite*\n\n*Key Responsibilities*\n\n* Drive software quality for digital health solutions including iOS/Android mobile apps, AWS/IBM Watson cloud, data reporting, AI/ML.\n* Develop and execute quality strategies with R&D, Regulatory, Marketing, and Operations teams.\n* Drive quality throughout the SDLC using Agile, Waterfall, SAFe, and DevOps.\n* Define/review requirements, design, verification & validation (V&V), test plans, and traceability.\n* Participate in design reviews and approve requirements, design documents, code reviews, test results, V&V reports, and defects.\n* Lead software risk management, system risk analysis, and Software FMEA.\n* Lead CAPA projects and support internal/external regulatory audits and inspections.\n* Drive compliance with ISO 13485, IEC 62304, ISO 14971, HIPAA, FDA, Security & Data Privacy requirements.\n* Establish and maintain software quality processes, procedures, metrics, documentation, and controls.\n* Evaluate software requirements, design, development, integration, testing, verification, and validation.\n* Ensure traceability, testability, documentation, and process compliance.\n\n*Minimum Qualifications*\n\n* Bachelor’s degree in Engineering, Science, or Technical field + 4+ years Engineering/Software Development/Quality experience.\n* OR Advanced degree in Engineering, Science, or Technical field + 2+ years relevant experience.\n\n*Nice to Have*\n\n* Software design, development, V&V, and testing experience.\n* Embedded software/mobile apps: Java, Objective-C, Kotlin, Swift.\n* Cloud: AWS, Azure, IBM Watson.\n* ALM/Defect/Development/Test/CI-CD: PTC Integrity, Atlassian, TFS, Jira, Git, GitLab, Android Studio, Selenium, JUnit, Jenkins.\n* Medical device standards: ISO 13485, IEC 62304, ISO 14971, HIPAA, FDA, Security/Data Privacy.\n* AI/ML, data-driven solutions, wireless/Bluetooth, n-tier architecture, ITIL.\n* Digital health systems and Apple/Android products.\n* Certifications: Scrum Master, SAFe, Black Belt, Green Belt, or CQE.\n\n*Must-Have Technical Skills*\n\nISO 62304 | ISO 14971 | Risk Management | New Product Development | Defect Management | Software V&V | Agile Methodology\n\nIND\\_ENG\n\nPay: $50.00 - $55.00 per hour\n\nExpected hours: 40.0 per week\n\nExperience:\n* Software development: 4 years (Preferred)\n* relevant: 2 years (Preferred)\n\nWork Location: In person","datePosted":"2026-09-02T10:43:44.157Z","dateModified":"2026-09-02T10:43:44.157Z","hiringOrganization":{"@type":"Organization","name":"Three Point Solutions","sameAs":"https://jobsearcher.com"},"jobLocation":{"@type":"Place","address":{"@type":"PostalAddress","addressLocality":"Northridge","addressRegion":"CA","addressCountry":"US"}},"identifier":{"@type":"PropertyValue","name":"JobSearcher","value":"dfca193ea373a5b2f2649015"},"url":"https://jobsearcher.com/jobs/dfca193ea373a5b2f2649015"}}