Overview

This candidate will ensure the quality and integrity of software development processes and configuration/change management. This role bridges quality assurance and software engineering, supporting compliance with IEC 62304, ISO 13485, and SOC2 requirements for medical device software while managing configuration baselines, change control processes, and release management.

Key Responsibilities

• Develop and maintain software quality assurance processes aligned with IEC 62304, ISO , ISO 13485, and applicable regulatory standards.
• Own and manage the Configuration Management system, including configuration identification, baselines, change control, and status accounting.
• Establish and maintain change management processes, ensuring traceability from requirements through design, implementation, testing, and release.
• Collaborate with engineering teams to define and enforce software development lifecycle, best practices, in...