Work Flexibility: Remote or Hybrid or Onsite
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 Hub. In 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.
What You Will DoSoftware Quality Systems and Lifecycle Support- 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.
Audit and Compliance Readiness- 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.
Cross-Functional Partnership and Process Improvement- 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.
What You Need- Bachelor's 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.
Preferred Qualifications- 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 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: $102,600 - $171,000 USD Annual
- US5: $107,700 - $179,600 USD Annual
- US10: $112,900 - $188,100 USD Annual
- US15: $118,000 - $196,600 USD Annual
- US20: $123,100 - $205,200 USD Annual
- US30: $133,400 - $222,300 USD Annual
View the U.S. work location and transparency guide to find the pay range for your location.
Travel Percentage: 10%
