BillionToOne
Quality Engineer, Prenatal
About this role
BillionToOne seeks an experienced Quality Engineer to drive process improvements and ensure regulatory compliance for prenatal diagnostic operations. This onsite role in Union City, CA involves cross-functional collaboration to enhance lab operations, manage quality incidents, and implement continuous improvements in a publicly traded genomics company.
What you'll do
- Collaborate with lab operations, bioinformatics, and software engineering teams to monitor operations and identify improvements
- Lead occurrence management activities including nonconformances, CAPAs, deviations, and complaints
- Develop and maintain quality assurance programs ensuring compliance with CLIA, CAP, NYSDOH, and FDA regulations
- Mentor laboratory staff and cross-functional teams on quality processes and best practices
- Review technical specifications, risk management, and validation protocols for quality assurance
- Track quality KPIs, analyze trends, and generate metrics reports
What they're looking for
- LDT (Laboratory Developed Test) expertise and regulatory knowledge
- Quality management systems and continuous improvement methodologies
- CLIA, CAP, FDA, and ISO compliance knowledge
- Project management and cross-functional coordination
- Data analysis and trend identification
- Technical writing and communication
- Bioinformatics and assay understanding
- Quality improvement tools (Lean, Six Sigma preferred)
Benefits
- Mission-driven work in precision medicine and genomics
- Opportunity to shape industry-leading diagnostics
- Collaborative, innovative team environment
- Onsite position in Union City, CA
- Mentorship and professional development opportunities
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BillionToOne
BillionToOne develops genomic diagnostics platforms for oncology and prenatal testing, leveraging Next Generation Sequencing and AI-driven technologies. The company is hiring for laboratory operations roles (equipment engineers, quality engineers) and software engineering positions to support its diagnostic services and healthcare technology platforms.
- Website
- billiontoone.com
Likely interview questions
- Can you walk us through your experience with LDT (Laboratory Developed Test) regulations, specifically CLIA, CAP, and any state-specific requirements you've worked with?
- Describe a time when you led a process improvement initiative from requirements gathering through implementation. What quality tools or methodologies did you use?