Senior Software (Quality Engineer 4) - CoE structure

Job Description

Primary Function of Position

The Senior Software Quality Engineer serves as a technical quality leader providing independent quality oversight for Software as a Medical Device (SaMD), Software in Medical Device (SiMD), Digital Health, AI/ML-enabled products, and cloud-connected healthcare solutions. This role partners closely with Software Engineering, Systems Engineering, Product Security, Regulatory Affairs, and Product Quality teams to drive quality by design throughout the software development lifecycle.

Unlike traditional quality roles focused primarily on documentation review and compliance activities, this position engages early in product development to identify technical risks, influence software quality practices, evaluate architecture decisions, promote testability, and strengthen software delivery processes while maintaining independent quality judgment.

The Senior Software Quality Engineer participates in requirements, architecture, design, verification, cybersecurity, and release readiness reviews as a technical quality partner. The role is responsible for ensuring software products are developed using sound engineering practices and comply with applicable regulatory, quality, cybersecurity, and risk management expectations.

This individual is expected to possess strong software engineering knowledge, a deep understanding of modern SDLC practices, and the ability to effectively challenge technical decisions through objective quality and risk-based assessment.

The Senior Software Quality Engineer serves as a technical quality partner and independent quality authority. The role actively participates in requirements, architecture, and design activities; however, ownership of engineering requirements, software architecture, implementation decisions, and design specifications remains with Engineering. The SW QE provides technical quality consultation, risk assessment, and independent oversight while maintaining objectivity for design control and release decisions.

Essential Job Duties:

Technical Quality Leadership

Serve as the Product Quality representative for software-intensive products and provide independent quality oversight across the software development lifecycle.

Partner with software and systems engineering teams to drive quality-by-design principles early in product development.

Participate in architecture, design, and technical review activities to identify quality, reliability, maintainability, and cybersecurity risks before implementation.

Evaluate software development practices and ensure alignment with industry-recognized engineering and quality principles.

Promote shift-left quality practices that prevent defects rather than relying solely on downstream verification activities.

Software Development Lifecycle Oversight

Assess software lifecycle execution against IEC 62304, FDA Quality System requirements, ISO 13485, and applicable organizational procedures.

Review software requirements, design specifications, risk controls, traceability structures, verification strategies, and release evidence to ensure lifecycle integrity.

Provide quality consultation on software development methodologies including Agile, DevOps, CI/CD, iterative development, and hybrid lifecycle models.

Evaluate software engineering deliverables for quality, completeness, maintainability, testability, and technical risk.

Architecture & Design Quality

Participate in software architecture and design reviews as an independent quality and risk management partner.

Assess system designs for scalability, modularity, reliability, resilience, maintainability, and testability.

Review integration architectures, interface designs, cloud-connected systems, APIs, embedded systems, and software platforms for quality and compliance concerns.

Challenge technical assumptions and facilitate risk-based discussions regarding design decisions and implementation approaches.

DevOps, Configuration Management & Release Quality

Evaluate software configuration management practices including source control, branching strategies, build management, release management, and product traceability.

Assess CI/CD pipelines and automated quality gates for effectiveness and regulatory compliance.

Review software release readiness criteria, build reproducibility controls, deployment processes, and software integrity safeguards.

Provide oversight of software bill of materials (SBOM), software configuration baselines, and release governance activities.

Verification, Validation & Test Engineering

Assess software verification and validation strategies using risk-based and quality-focused approaches.

Evaluate automation frameworks, test coverage, traceability, defect trends, and verification effectiveness.

Promote development of automated testing solutions including unit, integration, system, API, performance, and end-to-end testing approaches.

Drive testability considerations during requirements and architecture phases.

Cybersecurity & Secure Development

Evaluate software cybersecurity risks throughout the product lifecycle.

Collaborate with Product Security and Cybersecurity teams to promote Secure SDLC practices.

Participate in threat modeling, security risk assessments, vulnerability reviews, and cybersecurity readiness activities.

Support compliance with FDA cybersecurity guidance, NIST frameworks, and industry best practices for secure medical device development.

AI/ML & Digital Health Quality

Support quality and regulatory oversight of AI/ML-enabled software solutions.

Assess AI lifecycle controls related to data quality, model validation, bias mitigation, transparency, and traceability.

Promote risk-based validation strategies for AI-enabled healthcare products.

Support adoption of emerging technologies while maintaining patient safety, product quality, and regulatory compliance.

Quality Systems & Continuous Improvement

Support development and continuous improvement of software quality processes and procedures.

Participate in CAPA investigations, root cause analysis, audits, inspections, and continuous improvement initiatives.

Develop and monitor software quality metrics that support risk-based decision making.

Provide technical mentorship and guidance to engineering teams on software quality best practices.