Quality Engineer – Software & Configuration Management

About this role

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 147971, ISO 13485, and applicable regulatory standards for the AURA platform.

• 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 147971 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.