Sr. Software Quality Engineer in Los Angeles

• 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.

• 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

As a leading contract, contract-to-hire and professional placement firm, Three Point Solution understands the importance of aligning our client with the right resource at the right time. We are committed to the highest caliber of service that will benefit our clients, candidates and employees. Unlike large, corporate style recruiting firms, we commit to individualized attention that uniquely positions us to bridge the communication gap between recruiter, employer and candidate. Our goal is to cultivate and maintain true partnerships with our clients and candidates.

Company DescriptionAs a leading contract, contract-to-hire and professional placement firm, Three Point Solution understands the importance of aligning our client with the right resource at the right time. We are committed to the highest caliber of service that will benefit our clients, candidates and employees. Unlike large, corporate style recruiting firms, we commit to individualized attention that uniquely positions us to bridge the communication gap between recruiter, employer and candidate. Our goal is to cultivate and maintain true partnerships with our clients and candidates.