Illumina · 6 days ago
Quality Operations Engineer
San Diego, CA
Full-time
Onsite
New Grad, Entry Level
$63K/yr - $94K/yr
0+ years expIllumina is a company focused on expanding access to genomic technology to improve health equity globally. The Quality Operations Engineer role involves designing and maintaining quality assurance protocols, ensuring compliance with safety and regulatory standards, and analyzing production data to enhance quality processes.
BiotechnologyGeneticsHealth CareMedical
No H1B
Responsibilities
Trend, analyze, and report on quality data (metrics and KPIs) in order to improve product and process; develop recommendations from that analysis
Leverage knowledge of Quality processes to interrogate QMS data for ad hoc analyses, problem solving, and continuous improvement
Support the testing and debugging of dashboards detailing Quality metrics to ensure accuracy and adherence to user requirements
Provide management with status updates on assigned responsibilities and goals and escalate issues in a timely fashion
Collaborate and build relationships with counterparts and cross-functional teams at other Illumina sites
Ensure adequacy of non-conformances and CAPA records, investigations, and corrective actions
Become familiar with the applicable technology to facilitate participation in technical discussions and risk-based decision making
Review equipment onboarding, calibration and preventative maintenance tickets and identify potential gaps for GMP compliance
Review change requests/notices/approvals for compliance to change requirements outlined in applicable WIs/Procedures
Develop and execute strategies to close gaps in an efficient, technical, and compliant manner
Coordinate issue resolution using a risk-based approach; coordinate projects and continuous improvement efforts requiring inputs from diverse teams
Ensure manufacturing processes meet requirements of FDA and ISO
Other activities as assigned
Qualification
Required
0-2 years experience in quality assurance field in a regulated environment; direct experience working in in-vitro diagnostic manufacturing preferred
Demonstrated experience and capability with MS Excel and data visualization tools such as Tableau or Power BI
Proficient in use of Microsoft Office (Word, Excel, Outlook, PowerPoint)
Preferred
Experience with MS Power Platform and Copilot
Proficient in SQL and Python
Proven ability to work in SAP
Working knowledge of Quality Management Systems
Comfortable with generating and/or executing test cases for dashboard visualizations
Benefits
Access to genomics sequencing
Family planning
Health/dental/vision
Retirement benefits
Paid time off
Company
Illumina
Illumina is an innovative technology and revolutionary assays aiming the analyze genetic variation and function.
5001-10000 employees
Funding
Current Stage
Public CompanyTotal Funding
$1.28BKey Investors
Bank of America
2024-09-06Post Ipo Debt· $500M
2023-01-04Post Ipo Debt· $750M
2000-07-28IPO
Leadership Team
Steven Barnard
Chief Technology Officer, Head of Research & Product Development
Jenny Lei Zheng
SVP & GM of Greater China
Recent News
businessweekly.co.uk
2026-01-11
BioWorld Financial Watch
2026-01-11
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