Work Flexibility: Remote or Hybrid or Onsite
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.
What You Will DoSoftware Quality Systems and Process Leadership- 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.
Software Lifecycle and Risk Management- 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.
Audit and Compliance Readiness- 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.
Cross-Functional Leadership- 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.
What You Need - 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.
Preferred Qualifications (You Do Not Need to Have All of These)- 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 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: $102,600 - $171,000 USD Annual
- USN: $118,000 - $196,700 USD Annual
- US5: $123,900 - $206,500 USD Annual
- US10: $129,800 - $216,400 USD Annual
- US15: $135,700 - $226,200 USD Annual
- US20: $141,600 - $236,000 USD Annual
- US30: $153,400 - $255,700 USD Annual
View the U.S. work location and transparency guide to find the pay range for your location.
Travel Percentage: 10%
