Sr. Software Quality Engineer

*Job title : Sr. Software Quality Engineer* *Client : Medical Device Manufacturing Company* *Duration : 12 months + possible extension* *Location : Northridge, CA* *Schedule : 1st Shift | New Haven site | 4 days/week onsite* *Key Responsibilities* * Drive software quality for digital health solutions including iOS/Android mobile apps, AWS/IBM Watson cloud, data reporting, AI/ML. * Develop and execute quality strategies with R&D, Regulatory, Marketing, and Operations teams. * Drive quality throughout the SDLC using Agile, Waterfall, SAFe, and DevOps. * Define/review requirements, design, verification & validation (V&V), test plans, and traceability. * Participate in design reviews and approve requirements, design documents, code reviews, test results, V&V reports, and defects. * Lead software risk management, system risk analysis, and Software FMEA. * Lead CAPA projects and support internal/external regulatory audits and inspections. * Drive compliance with ISO 13485, IEC 62304, ISO 14971, HIPAA, FDA, Security & Data Privacy requirements. * Establish and maintain software quality processes, procedures, metrics, documentation, and controls. * Evaluate software requirements, design, development, integration, testing, verification, and validation. * Ensure traceability, testability, documentation, and process compliance. *Minimum Qualifications* * Bachelor’s degree in Engineering, Science, or Technical field + 4+ years Engineering/Software Development/Quality experience. * OR Advanced degree in Engineering, Science, or Technical field + 2+ years relevant experience. *Nice to Have* * Software design, development, V&V, and testing experience. * Embedded software/mobile apps: Java, Objective-C, Kotlin, Swift. * Cloud: AWS, Azure, IBM Watson. * ALM/Defect/Development/Test/CI-CD: PTC Integrity, Atlassian, TFS, Jira, Git, GitLab, Android Studio, Selenium, JUnit, Jenkins. * Medical device standards: ISO 13485, IEC 62304, ISO 14971, HIPAA, FDA, Security/Data Privacy. * AI/ML, data-driven solutions, wireless/Bluetooth, n-tier architecture, ITIL. * Digital health systems and Apple/Android products. * Certifications: Scrum Master, SAFe, Black Belt, Green Belt, or CQE. *Must-Have Technical Skills* ISO 62304 | ISO 14971 | Risk Management | New Product Development | Defect Management | Software V&V | Agile Methodology IND\_ENG Pay: $50.00 - $55.00 per hour Expected hours: 40.0 per week Experience: * Software development: 4 years (Preferred) * relevant: 2 years (Preferred) Work Location: In person