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Agent guide: [/agents.md](https://www.wearedevelopers.com/agents.md). --- # Senior Staff Software Advance Quality Engineer - **Company:** Stryker Corporation - **Location:** Sacramento, CA, United States - **Experience:** Expert - **Salary:** $102,600.0 - $171,000.0 - **Contract:** Permanent contract - **Skills:** Testing (Software), Adobe InDesign, Agile Methodology, Software as a Service, Cloud Computing, Software Quality, Continuous Integration, DevOps, EHealth, Systems Development Life Cycle, Software Licensing Audit, Software Engineering, Software Requirements Analysis, Software Quality Assurance (SQA), Software Security, Information Technology - **Published:** July 29, 2026 - **Apply:** https://dejobs.org/x/x/7B56F66B22FB491AB5C653FDA9E6C11F/job/ ## About the Role * Bachelor's degree in Software Engineering, Computer Science, Engineering, Quality, or a related technical discipline is required. * Six or more years of professional experience in software quality, quality systems, software compliance, audit, or a related field supporting software, SaaS, cloud-based, or connected products is required. * Experience developing, implementing, maintaining, or improving software quality processes or procedures is required. Preferred Qualifications (You Do Not Need to Have All of These) * Master's degree or another advanced technical degree. * Professional experience in software engineering or development before transitioning into software quality, compliance, or quality systems. * Strong understanding of the software development lifecycle, including change control, risk management, audit readiness, and Quality Management System processes. * Experience partnering with software development or R&D teams to implement or improve software quality processes. * Experience supporting regulated software products, preferably within medical devices, digital health, healthcare technology, or another compliance-driven industry. * Experience with SOC 2, ISO 27001, HIPAA, FDA software expectations, 21 CFR Part 11, IEC 62304, ISO 14971, ISO 13485, or comparable frameworks. * Working knowledge of cloud platforms, DevOps, CI/CD, and software security controls. * Experience leading audits, gap assessments, remediation activities, quality investigations, or corrective and preventive actions. * Demonstrated ability to influence cross-functional teams, communicate complex requirements, and lead process improvements without direct authority. * Professional certification such as CSQE, CQE, CQA, or an equivalent quality or compliance credential. ## Description Stryker is seeking a Senior Staff Software Quality Assurance Engineer to support our Digital Platform Hub. In this role, you will partner with software R&D teams to establish, implement, and improve quality processes across digital, connected, SaaS, and cloud-based products. You will provide quality-system guidance throughout the software development lifecycle, support audit and compliance readiness, and translate regulatory and industry requirements into practical, scalable processes. You will collaborate with R&D, Product Security, Privacy, Regulatory Affairs, IT, Operations, and Quality to enable efficient and compliant software delivery. This is not a software testing or test-execution role. This position focuses on software quality systems, SDLC governance, risk management, audit readiness, and process improvement., * Serve as a software quality and compliance subject matter expert for software, SaaS, cloud-hosted, and connected products. * Guide software R&D teams through applicable Quality Management System processes, procedures, and documentation requirements. * Develop, maintain, and improve software quality procedures, work instructions, templates, and guidance documents. * Identify process gaps and lead continuous-improvement initiatives across the software development lifecycle. * Translate regulatory, quality, security, and compliance requirements into practical development processes. * Establish scalable quality practices that support compliant and efficient software delivery. * Assess emerging regulations and standards and determine their impact on software-development processes. Software Lifecycle and Risk Management * Provide quality guidance throughout requirements, design, development, change control, release, maintenance, and retirement activities. * Participate in design reviews, risk assessments, change assessments, and release-readiness reviews. * Ensure software quality and compliance risks are identified, evaluated, documented, and appropriately addressed. * Integrate quality and risk-management practices into Agile, DevOps, and CI/CD environments. * Review software quality deliverables and provide clear, risk-based guidance to project teams. Audit and Compliance Readiness * Support readiness activities for SOC 2, ISO 27001, HIPAA, FDA, and other applicable frameworks. * Partner with control owners to ensure controls are implemented, maintained, and supported by objective evidence. * Support internal and external audits through gap assessments, evidence collection, auditor interaction, and remediation. * Lead or support investigations, root-cause analysis, corrective actions, and effectiveness monitoring related to software quality issues. Cross-Functional Leadership * Partner with Software Engineering, Product Security, Privacy, Regulatory Affairs, IT, Operations, and Quality teams. * Mentor and coach teams on quality-system requirements, software risk management, and compliant development practices. * Influence technical and business stakeholders without direct authority. * Resolve conflicts between development priorities, delivery timelines, and quality or compliance requirements. * Promote the integration of quality, security, compliance, and risk management into software-development decisions. ## Related Videos - [From DevOps to Scaled DevOps: How We’re Rebuilding Continuous Delivery as a Platform](https://www.wearedevelopers.com/videos/100018-from-devops-to-scaled-devops-how-we-re-rebuilding-continuous-delivery-as-a-platform) - [Excellent Software Testing](https://www.wearedevelopers.com/videos/87-excellent-software-testing) - [DevOps Maturity Check – a way to balance autonomy and alignment](https://www.wearedevelopers.com/videos/58-devops-maturity-check-a-way-to-balance-autonomy-and-alignment) - [Quality Strategy with a side of Swiss Cheese](https://www.wearedevelopers.com/videos/467-quality-strategy-with-a-side-of-swiss-cheese) - [Let’s Talk Quality!](https://www.wearedevelopers.com/videos/100012-let-s-talk-quality) - [#90DaysOfDevOps - The DevOps Learning Journey](https://www.wearedevelopers.com/videos/548-90daysofdevops-the-devops-learning-journey) ## Related Articles - [What is Software Engineering?](https://www.wearedevelopers.com/magazine/289-what-is-software-engineering) - [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) - [The 8 Best Code Testing Tools](https://www.wearedevelopers.com/magazine/402-the-8-best-code-testing-tools) - [Top Characteristics of a Software Engineer](https://www.wearedevelopers.com/magazine/166-top-characteristics-of-a-software-engineer) - [7 Important Tips That Every Software Developer Should Know](https://www.wearedevelopers.com/magazine/101-7-important-tips-that-every-software-developer-should-know)