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. 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. BillionToOne is looking for a to join our Prenatal/UNITY team and support our quality and continuous improvement initiatives in clinical operations. The ideal candidate will be expected to understand and apply principles of quality management practices to the Clinical Laboratory and supporting functions of Client Services, Engineering, Reagent Manufacturing, Supply Chain, etc. TheQuality Associate is an on-site position and reports to the Quality Manager.
Quality Associate
Responsibilities:
Collaborate with cross-functional teams to develop and maintain standard operating procedures (SOPs) and work instructions through document lifecycle management
Review change status activities to ensure compliance with configuration management policies
Provide training and support to laboratory staff on quality assurance processes and procedures
Review and maintain facility, safety, equipment lifecycle, personnel, patient, processing, reagent and quality control records of the quality management system
Develop, implement, and maintain quality assurance programs and systems to ensure compliance with regulatory requirements (CLIA, CAP, NYSDOH, etc.) and industry best practices
Play a key role in the preparation of external audits and inspections by accreditation and regulatory agencies such as CLIA, CAP, NY, and county and state inspectors
Conduct internal audits and assessments to identify areas for improvement and implement corrective and preventive actions as needed
Ensure quality processes, initiatives, and issues of the clinical laboratory and other supporting laboratory operation functions are being addressed and raised in a proactive manner
Assist in the development and implementation of quality improvement projects and initiatives to enhance operational efficiency and effectiveness
Stay up-to-date with industry trends and regulatory changes to ensure compliance and best practices
Qualifications:
Bachelor of Science in Medical Technology, Biology, Chemistry, or related field
Minimum of 1 year of relevant experience in a high-complexity CLIA, CAP, or NYS accredited or certified laboratory
Knowledge of regulatory requirements and quality management principles
High degree of initiative and self-motivation
Excellent communication and interpersonal skills, with the ability to collaborate effectively with cross-functional teams
Detailed-oriented with analytical and problem-solving skills
Ability to successfully balance and manage multiple priorities in a fast-paced, deadline driven environment
Experience with ensuring and maintaining integrity and quality of the lab
Nice-To-Haves:
Ability to clearly communicate complex information to internal and external stakeholders
Experience working in or with quality assurance for a CLIA or CAP laboratory
Benefits And Perks:
Working alongside brilliant, kind, passionate and dedicated colleagues, in an empowering environment, toward a global vision, striving for a future in which transformative molecular diagnostics can help millions of patients
Open, transparent culture that includes weekly Town Hall meetings
The ability to indirectly or directly change the lives of hundreds of thousands patients
Multiple medical benefit options; employee premiums paid 100% of select plans, dependents covered up to 80%
Extremely generous Family Bonding Leave for new parents (16 weeks, paid at 100%)
Supplemental fertility benefits coverage
Retirement savings program including a 4% Company match
Increase paid time off with increased tenure
Latest and greatest hardware (laptop, lab equipment, facilities)
Daily on-site lunches provided from top eateries
A variety of perks on campus (state of the art gym, restaurant)
Free on-site EV charging (compatible with all EVs, including Tesla)
At BillionToOne, we are proud to offer a combination of a (1) base pay range (actual amount offered is based on experience and salary/equity options split that the candidate chooses), (2) generous equity options offering, (3) corporate bonus program, on top of (4) industry leading company benefits (free healthcare options, 401k match, very generous fully paid parental leave, etc.). For this position, we offer a total compensation package of $108,610 per year, including a base pay range of $75,029 - $85,748 per year. BillionToOne is a next-generation molecular diagnostics company on a mission to make powerful, accurate diagnostic tests accessible to everyone. Our revolutionary QCT molecular counting technology enhances disease detection resolution by over a thousandfold using cell-free DNA,a breakthrough that has already transformed the lives of over half a million patients worldwide. ### Our Impact
Unity Complete™ is the only non-invasive prenatal screen capable of assessing fetal risk for both common recessive conditions and aneuploidies from a single maternal blood sample. Our Northstar® liquid biopsy test uniquely combines treatment selection with real-time monitoring, giving oncologists unprecedented precision in cancer care. ### Our Growth
From $0 to $150M+ in Annual Recurring Revenue in just five years. In 2025, we completed one of the most successful IPOs for a medical diagnostics company, building on nearly $400M in private funding,including our $130M Series D in 2024 and backed by world-class investors including Hummingbird, Adams Street Partners, Neuberger Berman, Baillie Gifford, and Premji Invest. ### Our Recognition
Forbes named us one of America's Best Startup Employers for 2025 and we're Great Place to Work certified, with 100% of our people willing to go the extra mile, even as we've scaled to over 700 employees. ### Our Future
Headquartered in Menlo Park with facilities in Union City, CA, and a new lab opening in Austin, TX in 2027, we're continuing to push the boundaries of what's possible in molecular diagnostics. We're just getting started. ---
Ready to help us change the world, one molecule at a time? Learn more at billiontoone.com
