Responsibilities:

Collaborate with cross-functional teams, including laboratory operations, customer support, bioinformatics, software engineering, and assay development, to monitor and maintain operations, investigate issues, perform changes, and identify improvement. Partner with and drive occurrence management activities with cross-functional leads, including Nonconformances, CAPAs, Deviations, and Complaints. Develop or improve, implement, maintain, and monitor quality assurance programs and systems to ensure compliance with regulatory requirements (CLIA, CAP, NYSDOH, etc.). Provide hands-on training, partnership, and mentorship to laboratory staff, quality peers, and cross-functional personnel on quality processes, procedures, tools, and best practices as applicable. Partner with authors and provide quality review of technical requirements, design specifications, risk management, validation and verification protocols and reports, and other quality records as a part of laboratory operations, change control, and new product development. Support the internal audit program and other continuous improvement processes. Track quality KPIs, analyze trends, and generate metrics reports or presentations with discussion and conclusions. Contribute to additional QMS functions as needed, including supplier quality. Maintain compliance with applicable FDA, CLIA, CAP, and ISO requirements and related guidances.

Qualifications:

Bachelor's degree in a scientific or technical field. Minimum of 5 years of experience within the LDT industry and familiarity with relevant regulations and guidelines, such as CLIA, CAP, and state-specific requirements for LDTs. Equivalent or additional experience in medical devices under FDA and ISO. Passion for mentoring early-career quality peers and championing quality culture cross-functionally. Expertise in quality tools and practices, quality management systems, and continuous improvement methodologies. Comfortable navigating ambiguity and shifting priorities in a high-growth environment using proactive and creative thinking to make meaningful contributions. Strong project management skills with a track record of driving cross-functional initiatives to completion. Ability to drive results to established timelines, communicate effectively both in writing and verbally, and work independently and cross-functionally to implement systems and processes.

Nice-To-Haves:

Expertise in Quality Improvement such as Lean, Six Sigma, and Root Cause Analysis. Expertise in Product Quality such as Design Control, Risk Management, and Usability. Experience in Software Quality and related practices such as Agile/Scrum. Experience in practical teaching of topics relevant to this role and industry. Knowledge of

ISO 13485, ISO 14971, ISO 15189, IEC 62304, IEC

62366, and

ISO/IEC 42001.

Familiarity with electronic quality management systems (e.g., Arena, Medialab). Familiarity or expertise with data visualization tools (e.g., Tableau). Quality or Project Management certifications.

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 eligible employees (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) Free 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 $172,379 per year, including a base pay range of $123,262 - $133,981 per year. BillionToOne is an equal opportunity employer. We do not discriminate on the basis of race, religion, color, national origin, gender, sexual orientation, age, marital status, veteran status, or disability status. For more information about how we protect your information, we encourage you to review our Privacy Policy . 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. Unity Confirm™ enables non-invasive confirmation for high-risk screening results through the capture of intact circulating fetal cells using BillionToOne's Fetal Cell Capture™ Technology. 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 $400M+ annualized revenue run-rate in just 6 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? 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Quality Engineer, Prenatal