Staff Software Quality & Regulatory Engineer (Hybrid)

Stryker Corporation

Portage (MI)

Hybrid

USD 120,000 - 210,000

Full time

7 days ago

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Benefits offered by this job

Hybrid work model

Job summary

Stryker Corporation is seeking a Staff Software Design Quality Engineer to lead quality and regulatory activities for cloud-based, software-enabled medical solutions across multiple U.S. locations including Portage, MI.

The role emphasizes process excellence, risk management, and compliance within SDLC, not testing. Hybrid work arrangement with on-site presence several days per week; collaborate with software, cybersecurity, regulatory, privacy, IT, and operations teams to ensure quality is

Qualifications

Bachelor's degree in Engineering, Sciences, or related technical discipline.
Minimum 4 years of experience in a regulated industry (R&D, Quality, Software Eng, IT, Healthcare IT, or Systems Eng).
Experience with software lifecycle methodologies (Agile, SAFe, or Waterfall).

Responsibilities

Lead software quality and compliance activities for cloud-based SaaS medical software.
Guide product teams through quality system processes and design control documentation.
Conduct risk assessments and FMEA throughout development and sustaining activities.
Review quality deliverables and release readiness for regulatory compliance.
Develop quality procedures, templates, and governance for scalable software development.
Support audit readiness and corrective actions.
Integrate quality practices into Agile/DevOps/CI/CD environments.
Partner with engineering, regulatory, privacy, IT, and operations teams to drive quality decisions.