Job Description

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

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.

• 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.

• Strong understanding of international medical device/IVDR regulations and standards, including 21 CFR 820, ISO 13485, IEC 62304, and ISO 14971.
• Deep knowledge of software development best practices for digital health, Medical Device Data Systems, and cloud-based platforms.
• Exceptional analytical, problem-solving, and documentation skills.
• Excellent verbal and written communication abilities with strong stakeholder collaboration skills.
• Organized self-starter able to manage competing priorities in a fast-paced environment.

• Bachelor's or Master's degree in Engineering, Bioengineering, Bioinformatics, Computer Science, or related field.
• 5+ years of Software Quality Engineering experience, ideally in multiomics, bioinformatics, or digital health software development.
  

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