Sr Software Quality Engineer (San Diego)
Hydrogen GroupSan Diego, CA, USjob_description.job_card.variable_hours_ago
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- serp_jobs.job_card.temporary
job_description.job_card.job_descriptionStrong 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. ...
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 :
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Sr Quality Engineer • San Diego, CA, US