Senior Staff Software Advance Quality Engineer

Stryker • Washington, DC

17d • $102,600 - $255,700 • Remote

About The Position

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.

Requirements

• 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.

Nice To Haves

• 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.

Responsibilities

• 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.

Benefits

• Stryker Corporation is an equal opportunity employer. Qualified applicants will receive consideration for employment without regard to race, ethnicity, color, religion, sex, gender identity, sexual orientation, national origin, disability, or protected veteran status. Stryker is an EO employer – M/F/Veteran/Disability.
• Stryker Corporation will not discharge or in any other manner discriminate against employees or applicants because they have inquired about, discussed, or disclosed their own pay or the pay of another employee or applicant. However, employees who have access to the compensation information of other employees or applicants as a part of their essential job functions cannot disclose the pay of other employees or applicants to individuals who do not otherwise have access to compensation information, unless the disclosure is (a) in response to a formal complaint or charge, (b) in furtherance of an investigation, proceeding, hearing, or action, including an investigation conducted by the employer, or (c) consistent with the contractor’s legal duty to furnish information.

What This Job Offers

• Job Type: Full-time
• Career Level: Senior