Director of Quality

Ready to redefine what's possible in molecular diagnostics? Join a team of brilliant, passionate innovators determined to transform healthcare. At BillionToOne, we've built a category-defining, publicly traded company on Nasdaq where transparency fuels trust, collaboration drives breakthroughs, and every contribution moves the needle on our mission to make life-changing diagnostics accessible to all. We don't just aim for incremental improvements; we build products that are 10x better than anything that exists today. With over 700 employees, half a million patients helped, and one of the most successful IPOs in medical diagnostics history behind us, we're just getting started. Our scientists, engineers, sales executives, and visionaries are united by an unwavering commitment to changing the standard of care in prenatal and cancer diagnostics. This is where cutting-edge science meets human compassion, and every innovation you contribute helps remove the fear of the unknown from some of life's most critical medical moments. If you're driven by purpose, energized by innovation, and ready to help shape the future of precision medicine at scale, this is where you belong. As the Director of Quality , you will be responsible for leading operational quality initiatives that directly support our CLIA-certified laboratory operations. You will drive continuous improvement efforts focused on reducing nonconformances, minimizing deviations, optimizing receiving inspection processes, and implementing robust supplier controls. This role requires a hands-on leader who can work cross-functionally with Lab Operations, Supply Chain, RD, and other stakeholders to enhance the operational effectiveness of our quality systems. This role is an onsite role in Union City, CA and will report directly to the Vice President of QARA. Responsibilities: Lead and execute operational quality programs including incident management, material management, supplier management, trending/monitoring, and compliance Drive continuous improvement initiatives by conducting root cause analyses, implementing corrective actions, and optimizing processes to reduce nonconformances and enhance laboratory efficiency Partner directly with Lab Operations, Supply Chain, RD, and other stakeholders to solve problems and embed quality into daily workflows Serve as subject matter expert for operational quality matters; personally lead critical investigations and improvement projects as needed Driving systematic reduction of quality issues through root cause analysis, trend identification, and implementation of sustainable corrective actions Establishing and tracking operational quality metrics (NCR, CAPA, Change Control, Preventive Maintenance, etc.) to drive data-driven decision making Developing risk-based receiving inspection protocols that balance quality assurance with operational efficiency Establishing acceptance criteria and sampling plans for incoming materials, reagents, and consumables Ensuring laboratory quality systems operate effectively to support daily operations Supporting regulatory inspections (CAP, CLIA, state agencies) with a focus on operational readiness Build and develop a high-performing operational quality team; provide hands-on coaching, establish performance standards, and foster a culture of accountability and continuous improvement Mentoring team members on quality principles, regulatory requirements, and effective investigation techniques Drive standardization of operational quality processes across laboratory locations (as applicable) Support quality risk assessments for operational changes and new products Completes other duties as assigned Qualifications: 8+ years quality leadership experience in a CLIA-certified laboratory environment with demonstrated ability to lead and manage people and teams Deep understanding of CLIA, CAP, state laboratory regulations (including NYS Clinical Lab requirements) Proven track record of succes ... (truncated, view full listing at source)