Senior Staff Software Advance Quality Engineer

Stryker is a leading company in the medical technology field, and they are seeking a Senior Staff Software Quality Assurance Engineer to support their Digital Platform Hub. In this role, you will influence software quality practices, partner with software R&D teams, and ensure compliance throughout the software development lifecycle.

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

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
• 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