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 *****, ISO *****, and SOC2 requirements formedical device software while managing configuration baselines, change control processes, and release management.Key Responsibilities• Develop and maintain software quality assurance processes aligned with IEC *****, ISO ******, ISO *****, 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.
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