YOH Services LLC
Overview
Sr. Software Quality Engineer needed for a contract opportunity with Yoh Scientific's client located in San Diego, CA. This position is with a biotech company. Candidates should have a minimum of 5 years of experience in Software Quality Engineering, preferably within multi-omics or bioinformatics. Schedule: Hybrid, 40 hours a week, Monday - Friday. Responsibilities
Own all aspects of Software Design Quality for IVDR and RUO software, including risk management, design controls, and Design History File (DHF). Provide Software Quality Engineering support for project planning, requirements/specification development, software verification, design verification and validation, design transfer, process development, process validation, risk management, and/or human factors. Own risk management activities, including the Risk Management File (RMF), risk management plan, hazard analysis, DFMEA, and risk management report. Serve as the SME for Software Quality Engineering and collaborate with teams on code reviews, software security analysis, defect and vulnerability triage, creation and maintenance of sBOMs, and lead the implementation of best practices for software quality processes. Drive cross-functional engagement with stakeholders to optimize the success of development projects. Support audits to ensure the quality and completeness of product DHFs. Conduct root cause investigations of product complaints and quality issues, initiate corrective actions, and monitor the implementation and effectiveness of corrective actions where applicable. Support other areas of the company's Quality Management System (QMS), when applicable. Qualifications
Bachelor's Degree or Master's Degree in Engineering, Bioengineering, Bioinformatics, Computer Science, or related engineering field. 5+ years of experience in Software Quality Engineering, preferably within multiomics or bioinformatics. Strong understanding of international medical device/IVDR regulations and standards, including 21 CFR 820, ISO 13485, IEC 62304, and ISO 14971. Strong understanding of software development best practices for digital health software, Medical Device Data Systems, and cloud-based software/systems. Organized self-starter, able to work in a fast-paced environment. Exceptional analytical and problem-solving skills. Contract:
From start date until December 28, 2025 with possibility of extension or conversion to perm. Salary:
$42.50 - $53.25 per hour, W2. Recruiter:
Ery Baniqued Note
Yoh is an Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, disability, or status as a protected veteran. For California applicants, the Los Angeles County Fair Chance Ordinance and California Fair Chance Act may apply. By applying, you authorize Yoh to review and reformat your resume to meet hiring client preferences. For more information, visit Yoh's privacy notice.
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Sr. Software Quality Engineer needed for a contract opportunity with Yoh Scientific's client located in San Diego, CA. This position is with a biotech company. Candidates should have a minimum of 5 years of experience in Software Quality Engineering, preferably within multi-omics or bioinformatics. Schedule: Hybrid, 40 hours a week, Monday - Friday. Responsibilities
Own all aspects of Software Design Quality for IVDR and RUO software, including risk management, design controls, and Design History File (DHF). Provide Software Quality Engineering support for project planning, requirements/specification development, software verification, design verification and validation, design transfer, process development, process validation, risk management, and/or human factors. Own risk management activities, including the Risk Management File (RMF), risk management plan, hazard analysis, DFMEA, and risk management report. Serve as the SME for Software Quality Engineering and collaborate with teams on code reviews, software security analysis, defect and vulnerability triage, creation and maintenance of sBOMs, and lead the implementation of best practices for software quality processes. Drive cross-functional engagement with stakeholders to optimize the success of development projects. Support audits to ensure the quality and completeness of product DHFs. Conduct root cause investigations of product complaints and quality issues, initiate corrective actions, and monitor the implementation and effectiveness of corrective actions where applicable. Support other areas of the company's Quality Management System (QMS), when applicable. Qualifications
Bachelor's Degree or Master's Degree in Engineering, Bioengineering, Bioinformatics, Computer Science, or related engineering field. 5+ years of experience in Software Quality Engineering, preferably within multiomics or bioinformatics. Strong understanding of international medical device/IVDR regulations and standards, including 21 CFR 820, ISO 13485, IEC 62304, and ISO 14971. Strong understanding of software development best practices for digital health software, Medical Device Data Systems, and cloud-based software/systems. Organized self-starter, able to work in a fast-paced environment. Exceptional analytical and problem-solving skills. Contract:
From start date until December 28, 2025 with possibility of extension or conversion to perm. Salary:
$42.50 - $53.25 per hour, W2. Recruiter:
Ery Baniqued Note
Yoh is an Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, disability, or status as a protected veteran. For California applicants, the Los Angeles County Fair Chance Ordinance and California Fair Chance Act may apply. By applying, you authorize Yoh to review and reformat your resume to meet hiring client preferences. For more information, visit Yoh's privacy notice.
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