Software Qa & Configuration Management Engineer

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, including code reviews and testing standards.
• Manage configuration items across mechatronics, software, and documentation, ensuring version control integrity and audit readiness.
• Support software verification and validation activities, including test plan review, test case development, and defect tracking.
• Generate configuration status reports, change request logs, and rel...