Staff Cloud Software Quality & Compliance Engineer

Stryker; California (MO); On-site; USD 103,000 - 222,000; Full time

Benefits offered by this job

Health benefits

401(k) plan

Wellbeing program

Job summary

Stryker in the United States is seeking a Software Quality professional to strengthen quality practices across a growing portfolio of digital and connected solutions. You will guide software teams through QMS processes and support audit readiness.

This role focuses on SDLC governance, risk management, and process improvement across Agile, DevOps, and CI/CD environments, with opportunities to influence cross-functional stakeholders.

Qualifications

• Bachelor’s degree in Software Engineering, Computer Science, Engineering, Quality, or related technical discipline.
• 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.
• Experience developing, implementing, maintaining, or improving software quality processes or procedures.

Responsibilities

• Guide software teams through 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 addressed.
• Support quality practices within Agile, DevOps, and CI/CD environments.
• Support SOC 2, ISO 27001, HIPAA, FDA and other compliance activities.

Skills

Software quality

Audit readiness

Regulatory knowledge

Cross-functional collaboration

Education

Bachelor's degree in Software Engineering, Computer Science, Engineering, Quality, or related technical discipline

Tools

QMS

SOC 2 / ISO 27001

HIPAA / FDA software expectations

21 CFR Part 11 / IEC 62304

ISO 13485

Job description

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.

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.

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

View the U.S. work location and transparency guide to find the pay range for your location.

• Health benefits include: Medical and prescription drug insurance, dental insurance, vision insurance, critical illness insurance, accident insurance, hospital indemnity insurance, personalized healthcare support, wellbeing program and tobacco cessation program.
• Financial benefits include: Health Savings Account (HSA), Flexible Spending Accounts (FSAs), 401(k) plan, Employee Stock Purchase Plan (ESPP), basic life and AD&D insurance, and short-term disability insurance.

Stryker offers innovative products and services in MedSurg, Neurotechnology, Orthopaedics and Spine that help improve patient and healthcare outcomes. Alongside its customers around the world, Stryker impacts more than 150 million patients annually. Depending on customer requirements employees and new hires in sales and field roles that require access to customer accounts as a function of the job may be required to obtain various vaccinations as an essential function of their role.