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Agent guide: [/agents.md](https://www.wearedevelopers.com/agents.md). --- # Staff Software Quality Engineer - **Company:** iRhythm Technologies, Inc. - **Location:** Cypress, CA, United States - **Salary:** $127,000.0 - $165,000.0 - **Contract:** Permanent contract - **Skills:** Artificial Intelligence, Software Applications, JIRA, Automation of Tests, Configuration Management, Software Quality, Custom Software, DevOps, Programming Tools, Software Product Management, Software Tools, Toolchain, Automated Data Processing (ADP), Iq/oq/pq, Git, Information Technology, GXP - **Published:** May 23, 2026 - **Apply:** https://www.indeed.com/viewjob?jk=dbd6c099479dfb80 ## About the Role Do you have experience in Mentoring?, Do you have a Master's degree?, * Typically requires a minimum of 12 years of related experience with a Bachelor's degree in Computer Science, Biomedical Engineering, or related technical field; or 8 years and a Master's degree; or equivalent work experience. Knowledge, Skills and Abilities: * Regulatory Knowledge: Deep understanding of FDA 21 CFR Part 820, Part 11, IEC 62304 standards and GAMP5. * NPS Expertise: Demonstrated experience with validating custom software, tools and fixtures for device manufacturing and processing, DevOps toolchains (e.g., Jira, Git), test automation, and/or GxP applications supporting QMS and other GxP business processes. * Technical Skills: Experience implementing risk-based testing (CSA) and automated testing tools. * Soft Skills: Proven ability to lead cross-functional projects, mentor junior engineers, and communicate complex compliance requirements to technical and non-technical stakeholders. * Preferred skills: Experience with SaMD / AI-enabled medical devices. Work Environment / Other Requirements: * iOC based * Hybrid role with a minimum of 3 days on site ## Description The Staff Software Quality Engineer for Non-Product Software (NPS) will be the technical lead and subject matter expert (SME) responsible for the strategy, validation, and compliance of software tools used in the development and manufacturing of Medical Device., * NPS Validation Strategy: Define and lead the Computer Software Assurance (CSA) strategy and validation master plans for new and existing non-product software. * Risk Management: Apply risk-based testing methodologies to determine the appropriate rigor of validation for manufacturing, QMS, and development tools. * Compliance Leadership: Ensure all NPS activities comply with 21 CFR Part 11 (electronic records/signatures) and ISO 13485. * Documentation Oversight: Review, approve and occasionally author validation plans, software V&V, installation qualification (IQ), operational qualification (OQ), and performance qualification (PQ) protocols/reports. * Tool Qualification: Lead the qualification of software-based test, manufacturing and processing equipment, automated data processing systems, and design tools. * Cross-functional Collaboration: Partner with Manufacturing, IT, DevOps, and R&D teams to identify software needs and implement compliant workflows. * Audit Readiness: Act as the technical lead for NPS during internal and external audits (FDA, ISO, Notified Bodies). * Change Control: Manage software changes, updates, and patches via rigorous configuration management processes. ## Related Videos - [Improving quality with Agentic AI with Rovo Dev and Xray](https://www.wearedevelopers.com/videos/2005-improving-quality-with-agentic-ai-with-rovo-dev-and-xray) - [More efficient software for more efficient microchips](https://www.wearedevelopers.com/videos/1164-more-efficient-software-for-more-efficient-microchips) - [Blueprints for Success: Steering a Global Data & AI Architecture](https://www.wearedevelopers.com/videos/1577-blueprints-for-success-steering-a-global-data-ai-architecture) - [How a Small Team Shrank a Microsoft Monorepo by 94%](https://www.wearedevelopers.com/videos/1236-how-a-small-team-shrank-a-microsoft-monorepo-by-94) - [AIQSpecFlow: Improves and automates your agile process of specification and creation of testcases.](https://www.wearedevelopers.com/videos/100084-aiqspecflow-improves-and-automates-your-agile-process-of-specification-and-creation-of-testcases) - [Collaboration Quantified: Lessons from Open Source Developer Networks](https://www.wearedevelopers.com/videos/1422-collaboration-quantified-lessons-from-open-source-developer-networks) ## Related Articles - [Fully Remote Software Engineer Jobs](https://www.wearedevelopers.com/magazine/447-fully-remote-software-engineer-jobs) - [The 8 Best Code Testing Tools](https://www.wearedevelopers.com/magazine/402-the-8-best-code-testing-tools) - [Now is the time for industrialized software development](https://www.wearedevelopers.com/magazine/601-now-is-the-time-for-industrialized-software-development) - [The 12 Best Jobs for Software Engineers](https://www.wearedevelopers.com/magazine/401-the-12-best-jobs-for-software-engineers) - [Is Software Engineering Over-Saturated?](https://www.wearedevelopers.com/magazine/418-is-software-engineering-over-saturated) - [Résumé-Driven Development: How IT trends affect the job market for software developers](https://www.wearedevelopers.com/magazine/59-resume-driven-development-how-it-trends-affect-the-job-market-for-software-developers)