Senior Staff Software Advance Quality Engineer

It’s Time to Join Stryker!
Why Join Us

In this role, you will help shape software quality practices across a growing portfolio of digital and connected solutions. You will influence how software teams incorporate quality, compliance, security, and risk management into development while establishing scalable processes that support innovation and efficient delivery.

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.

• 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, Dev Ops, and CI/CD environments.
• Review software quality deliverables and provide clear, risk-based guidance to project teams.

• 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.

• 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.

• 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.