Sr Software Quality Engineer

Job Title : SR Software Quality Engineer

Location : San Diego, CA (Hybrid)

Schedule : Standard Office Hours

Duration : 2-Month Contract

Pay Rate Range : $42.50 - $53.25 / hour

Job Summary :

The Software Quality Engineer will be responsible for ensuring software compliance with international regulatory and quality standards across research-use-only (RUO) and IVDR-regulated software. This role includes risk management, design controls, Design History File (DHF) management, and supporting software development best practices to drive compliance, reliability, and continuous improvement.

Job Responsibilities :

• Lead all aspects of Software Design Quality for IVDR and RUO software, including design controls, risk management, and DHF ownership.
• Provide Software Quality Engineering support for project planning, requirements development, software verification, design validation, design transfer, process development, process validation, and human factors activities.
• Manage risk management activities, including creation and maintenance of RMFs, risk plans, hazard analyses, dFMEAs, and risk reports.
• Serve as subject matter expert (SME) for Software Quality Engineering, supporting code reviews, software security analysis, vulnerability triage, and sBOM development / maintenance.
• Lead implementation of best practices for software quality processes across development teams.
• Support audits to ensure completeness and compliance of DHFs.
• Conduct root cause investigations of complaints and software-related quality issues; initiate and monitor corrective actions for effectiveness.
• Support other aspects of the Quality Management System (QMS) as needed.

Knowledge & Skills :

Education & Experience :