Staff Cloud Software Quality & Compliance Engineer

Stryker Corporation; Dallas (TX); Hybrid; USD 103,000 - 222,000; Full time

Job summary

Stryker Corporation in the United States seeks a Staff Software Quality Assurance Engineer to strengthen quality systems across digital, connected, SaaS, and cloud products. You will partner with software R&D teams to implement governance, risk management, and audit readiness throughout the SDLC.

This role focuses on quality processes rather than testing, supporting SOC 2, ISO 27001, HIPAA, and FDA requirements, with cross‑functional collaboration across Engineering, Regulatory, IT, and Quality

Qualifications

• Bachelor’s degree in a related technical discipline is required.
• Four or more years of professional software quality or related experience is required.
• Experience developing or improving software quality processes or procedures is required.

Responsibilities

• Guide software teams through Quality Management System processes and documentation requirements.
• Develop and improve software quality procedures, templates, and guidance documents.
• Provide quality support across requirements, design, development, testing, release, and operations.

Skills

Quality Assurance

Regulatory compliance

Audit readiness

SDLC governance

Cross‑functional collaboration

Education

Bachelor’s degree in Software Engineering/CS/Engineering/Quality

Master’s degree (preferred)

Job description

Work Flexibility: Remote or Hybrid or Onsite It’s Time to Join Stryker! Why Join Us 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 Do

• Software 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

Travel Percentage: 10%

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.

Stryker is one of the world’s leading medical technology companies and, together with its customers, is driven to make healthcare better. We offer innovative products and services in Orthopaedics, Medical and Surgical, and Neurotechnology and Spine that help improve patient and hospital outcomes. We are proud to be named one of the World’s Best Workplaces! For more information, visit: www.stryker.com

Work Flexibility Remote – Role allows you to work the majority to 100% of time from an alternate workplace. These roles could have travel expectations, and you must work within the country of the job requisition location. Field-based – You can expect to regularly work a majority to 100% of time at customer facilities and has a set territory or expectation to travel within a set boundary. Almost all sales roles would likely be qualified as field-based. Onsite – Role is 100% located at a Stryker facility. Some ad hoc flexibility may be available depending on role, level, and job requirements. Manufacturing roles and any role that requires physical presence at the office would qualify under this category. Hybrid – You can expect to regularly work in both an alternate workplace and a Stryker facility. Roles that are partially remote or co-located would qualify as hybrid, and the expectation to be onsite would be defined and agreed upon by your manager/supervisor.