Senior Software Quality Engineer

Senior Software Quality Engineer - Remote Seeking a Senior Software Quality Engineer to serve as a technical quality leader supporting software-enabled and connected medical device systems. This role partners closely with Software Engineering, Systems Engineering, Manufacturing, and cross-functional teams to ensure compliant, secure, and high-quality product development throughout the software lifecycle. Key Qualifications: Bachelor's degree in Computer Science, Software Engineering, Biomedical Engineering, or related field 5+ years of experience in software quality, software validation, software development, or a regulated industry (medical device, pharma, etc.) Strong understanding of Software Development Lifecycle (SDLC), Design Controls, verification & validation, and risk management Experience with software validation, traceability, requirements management, and test execution Knowledge of ISO 13485, ISO 14971, IEC 62304, usability engineering, and cybersecurity principles Experience supporting QMS tools, change control, software releases, and audit readiness Strong analytical, documentation, problem-solving, and cross-functional communication skills This is an excellent opportunity for a quality professional who enjoys working at the intersection of software, quality, regulatory compliance, and connected healthcare technologies, helping to drive product quality and continuous improvement across the development lifecycle. Remote US role; preference in/around Chicago or WI for site visits. Comp: $110-140k base salary plus 15% bonus