Staff Software Quality Assurance Engineer

Job Summary

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