Senior Software Quality Engineer

Salary: $102,600 - 255,700 per year Requirements:

• We require a bachelors degree in Software Engineering, Computer Science, Engineering, Quality, or a related technical field.
• We require at least six years of professional experience in software quality, quality systems, software compliance, audit work, or a similar area supporting software, SaaS, cloud-based, or connected products.
• We require experience creating, implementing, sustaining, or improving software quality processes or procedures.
• Preferred experience includes an advanced degree, prior software engineering or development experience, a strong understanding of SDLC, change control, risk management, audit readiness, and QMS practices.
• Preferred experience includes working with regulated software products, especially in medical devices, digital health, healthcare technology, or other compliance-focused industries.
• Preferred knowledge includes SOC 2, ISO 27001, HIPAA, FDA software expectations, 21 CFR Part 11, IEC 62304, ISO 14971, ISO 13485, or similar frameworks.
• Preferred knowledge includes cloud platforms, DevOps, CI/CD, and software security controls.
• Preferred experience includes leading audits, gap assessments, remediation efforts, investigations, or corrective and preventive actions.
• Preferred ability includes influencing cross-functional teams, communicating complex requirements clearly, and driving process improvements without direct authority.
• Preferred professional certifications include CSQE, CQE, CQA, or an equivalent quality or compliance credential.

• We serve as a subject matter expert in software quality and compliance for software, SaaS, cloud-hosted, and connected products.
• We guide software R&D teams through Quality Management System processes, procedures, and documentation expectations.
• We develop, maintain, and refine software quality procedures, work instructions, templates, and supporting guidance.
• We identify process gaps and lead continuous improvement across the software development lifecycle.
• We translate regulatory, quality, security, and compliance requirements into practical development workflows.
• We build scalable quality practices that enable efficient and compliant software delivery.
• We assess emerging regulations and standards and evaluate their impact on software development processes.
• We provide quality guidance throughout requirements, design, development, change control, release, maintenance, and retirement phases.
• We participate in design reviews, risk assessments, change assessments, and release readiness reviews.
• We ensure software quality and compliance risks are identified, assessed, documented, and addressed appropriately.
• We integrate quality and risk management practices into Agile, DevOps, and CI/CD environments.
• We review quality deliverables and provide clear, risk-based direction to project teams.
• We support readiness efforts for SOC 2, ISO 27001, HIPAA, FDA, and other applicable frameworks.
• We partner with control owners to ensure controls are implemented, maintained, and supported by objective evidence.
• We support internal and external audits through gap assessments, evidence gathering, auditor engagement, and remediation.
• We lead or support investigations, root-cause analysis, corrective actions, and effectiveness checks related to software quality issues.
• We partner closely with Software Engineering, Product Security, Privacy, Regulatory Affairs, IT, Operations, and Quality teams.
• We mentor and coach teams on quality-system requirements, software risk management, and compliant development practices.
• We influence technical and business stakeholders without direct authority.
• We resolve conflicts between delivery priorities and quality or compliance expectations.
• We promote the integration of quality, security, compliance, and risk management into software decisions.

• CI/CD
• Cloud
• DevOps
• Support
• Security

More:

We are Stryker, and we are hiring a Senior Staff Software Quality Assurance Engineer for our Digital Platform Hub. This role is flexible and can be remote, hybrid, or onsite. You will help strengthen software quality practices across our expanding portfolio of digital, connected, SaaS, and cloud-based solutions. We offer a collaborative environment where you will work with R&D and cross-functional partners to support compliant, scalable software delivery. The role includes a travel expectation of 10%, and the posted U.S. pay ranges vary by location.

last updated 33 week of 2026