Senior Staff Software Advance Quality Engineer

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 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 DevOps 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.

• Bachelors 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.

• Masters 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.

United States of America Pay Ranges:

• Puerto Rico: $102600 - $171000 USD Annual
• USN: $118000 - $196700 USD Annual
• US5: $123900 - $206500 USD Annual
• US10: $129800 - $216400 USD Annual
• US15: $135700 - $226200 USD Annual
• US20: $141600 - $236000 USD Annual
• US30: $153400 - $255700 USD Annual