Key responsibilities
* develop and maintain software quality assurance processes aligned with iec 62304, iso 147971, 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 notes for stakeholders.
qualifications
* bachelor's degree in electrical engineering, software engineering, computer science, or related field.
* experience with iec 62304, iso 14971 and iso 13485 for medical device software.
* static code analysis tools and code coverage verification.
* software verification and validation methodologies.
* software development lifecycle methodologies (agile, v-model).
* 3-5 years of experience in software quality assurance, configuration management in regulated industries.
* proficiency in jira, confluence, and ci/cd platforms.
* familiarity with soc2 change management requirements.
* english full professional proficiency.
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