A Rare Opportunity to Shape the Future of Genomics 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.

We are looking for a Quality Engineer, Prenatal Lab Operations with a strong background in the LDT environment and expertise in lab practices, bioinformatics, report automation, assays, and reagents. Additionally, you will possess a deep understanding of quality tools and practices to ensure the highest standards of our products and services. g.

Lab Operations, Bioinformatics, Process Engineering, Software Engineering, R&D).

Requirements

gathering to go-live and further continuous improvement. This role is an onsite position in Union City, CA and reports to the Quality Manager, Prenatal.

, 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.

and related guidances.

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.

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.

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.

Qualifications

: Bachelor's degree in a scientific or technical field.