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About This Opportunity
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 release ...