Senior Software Quality Engineer

Accordance Search Group•Chicago, IL

2d•Remote

About The Position

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. 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.

Requirements

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

Responsibilities

Serve as a technical quality leader supporting software-enabled and connected medical device systems.
Partner closely with Software Engineering, Systems Engineering, Manufacturing, and cross-functional teams to ensure compliant, secure, and high-quality product development throughout the software lifecycle.
Drive product quality and continuous improvement across the development lifecycle.