Staff Software Quality Assurance Engineer

A company is looking for a Staff SW Quality Assurance Engineer (Hybrid). Key Responsibilities Lead Quality Assurance and Quality Engineering activities throughout the Software Development Lifecycle for medical devices Ensure compliance with IEC 62304 and FDA Guidance on software submissions Establish and maintain software quality assurance processes to ensure regulatory compliance Required Qualifications BS degree in computer science, computer engineering, or equivalent field; Master's degree preferred A minimum of 8 years of experience in Software Quality Engineering within a regulated environment Experience with medical device software development, including cloud-based systems and cybersecurity Working knowledge of FDA Quality System Regulation and ISO 13485 standards Familiarity with IEC 62304, ISO 14971, and related software development guidelines