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BillionToOne is a publicly traded genomics company transforming prenatal and cancer diagnostics. This Quality Engineer role focuses on prenatal lab operations and reports to the Quality Manager, Prenatal.
You will drive quality and operational excellence across the prenatal diagnostic lab, working at the intersection of laboratory operations, bioinformatics, process engineering, and software development. Key responsibilities include:
• Collaborate with cross-functional teams (lab ops, customer support, bioinformatics, software engineering, assay development) to monitor operations, investigate issues, and identify improvements.
• Lead occurrence management activities including nonconformances, CAPAs, deviations, and complaints across the prenatal business unit.
• Develop, implement, and maintain quality assurance programs ensuring compliance with CLIA, CAP, NYSDOH, and other regulatory requirements.
• Mentor laboratory staff and quality peers on quality processes, procedures, and best practices.
• Partner with technical teams on quality review of requirements, design specifications, risk management, validation protocols, and quality records.
• Support internal audit programs and continuous improvement initiatives.
• Track quality KPIs, analyze trends, and generate metrics reports with actionable insights.
• Contribute to broader QMS functions including supplier quality.
You bring a minimum of 5 years in the LDT (Laboratory Developed Test) industry with deep familiarity of CLIA, CAP, and state-specific regulations. You have expertise in quality tools, QMS, and continuous improvement methodologies. You're comfortable in high-growth environments, excel at cross-functional collaboration, and have strong project management skills. A Bachelor's degree in a scientific or technical field is required.
Nice-to-haves include Lean/Six Sigma, Design Control, Risk Management, Software Quality practices, ISO certifications (13485, 14971, 15189, IEC 62304), and experience with quality management systems like Arena or Medialab.
