Software Quality LeadWe are seeking a Software Quality Lead to lead verification and validation for the Neo project. This role will define the test strategy, oversee test planning and execution, and ensure the product meets its requirements, quality objectives, and applicable regulatory expectations. The Software Quality Lead will partner closely with systems engineering, software development, product management, regulatory, quality, cybersecurity, and program leadership. The role will drive a risk-based approach to software quality while ensuring compliance with Quality Management System processes, medical-device design controls, and applicable regulatory requirements.
Key Responsibilities:
Develop and lead the overall test strategy, test planning, and execution approach to ensure comprehensive verification and validation of product requirements.
Lead verification of cloud services, applications, APIs, interfaces, and system integrations.
Lead V&V activities to ensure adherence to QMS processes, regulatory requirements, and product quality objectives.
Ensure traceability among requirements, risk controls, test cases, defects, and test results.
Define test methods, environments, acceptance criteria, and entry and exit criteria.
Drive risk-based testing, defect triage, root-cause analysis, and release-readiness assessments.
Establish quality metrics and communicate test progress, product risks, and unresolved issues.
Help drive adoption of AI-enabled, spec-driven software development practices to improve requirement quality, testability, traceability, and V&V efficiency.
Advance test automation and continuous testing within CI/CD pipelines.
Support design reviews, regulatory submissions, audits, and quality-system inspections.
Mentor team members and promote shared ownership of product quality.
Qualifications:
Bachelor's degree in Computer Science, Software Engineering, Biomedical Engineering, or a related field.5+ years experience in software testing, quality engineering, and V&V activities.
Demonstrated experience leading V&V for complex software products.
Strong knowledge of test strategy, requirements traceability, risk-based testing, and defect management.
Experience testing cloud applications, APIs, distributed systems, or system integrations.
Excellent analytical, communication, collaboration, and documentation skills.
Preferred Qualifications:
Experience with medical devices, healthcare products, or another regulated industry.
Knowledge of QMS processes, design controls, risk management, and regulatory requirements.
Knowledge of medical device standards and design controls.
Experience with AWS, test automation, CI/CD pipelines, and cybersecurity verification.
Experience supporting regulatory submissions and audits.
What Success Looks Like:
Establishes a clear, risk-based V&V strategy aligned across the project.
Delivers comprehensive verification coverage and traceable objective evidence.
Ensures V&V activities comply with QMS and regulatory requirements.
Identifies quality and testability issues early in development.
Provides clear assessments of test progress, product quality, and release risk.
Improves testing efficiency and consistency through automation and continuous improvement.
Builds strong partnerships and raises the team's overall quality capability.
