Staff Cloud Software Quality & Compliance Engineer

In this role you will help strengthen software quality practices across a growing portfolio of digital and connected solutions. You will work with software teams to improve lifecycle quality support audit readiness and enable compliant efficient software delivery.

Stryker is seeking a Staff Software Quality Assurance Engineer to support our Digital Platform this role you will partner with software R&D teams to implement and improve quality processes across digital connected SaaS and cloud-based products.

You will provide quality guidance throughout the software development lifecycle support audit and compliance readiness and help translate regulatory and industry requirements into practical scalable processes.

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.

• Guide software teams through applicable Quality Management System processes procedures and documentation requirements.
• Develop and improve software quality procedures work instructions templates and guidance documents.
• Provide quality support across requirements design development testing release operations and software change-management activities.
• Participate in design reviews risk assessments change assessments and release-readiness activities.
• Help ensure software quality and compliance risks are identified documented and appropriately addressed.
• Support quality practices within Agile DevOps and CI/CD environments.

• Support SOC 2 ISO 27001 HIPAA FDA and other applicable compliance and audit-readiness activities.
• Partner with control owners to ensure controls are maintained and supported by appropriate evidence.
• Support internal and external audits through gap assessments evidence collection remediation and audit preparation.
• Participate in investigations root-cause analysis corrective actions and effectiveness monitoring.

• Partner with Software Engineering Test Engineering Product Security Privacy Regulatory Affairs IT Operations and Quality.
• Identify process gaps and support improvements that strengthen consistency efficiency and compliance.
• Translate quality regulatory security and compliance requirements into practical development processes.
• Influence cross-functional stakeholders and help resolve conflicts between development priorities and quality requirements.

• Bachelors degree in Software Engineering Computer Science Engineering Quality or a related technical discipline is required
• Four 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 supporting audits gap assessments remediation activities quality investigations or corrective and preventive actions.
• Demonstrated ability to influence cross-functional teams communicate complex requirements and support 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:

• USN: $102600 - $171000 USD Annual
• US5: $107700 - $179600 USD Annual
• US10: $112900 - $188100 USD Annual
• US15: $118000 - $196600 USD Annual
• US20: $123100 - $205200 USD Annual
• US30: $133400 - $222300 USD Annual