Quality Associate

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. BillionToOne is looking for a Quality Associate 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. The Quality Associate is an on-site position and reports to the Quality Manager. 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 Bene ... (truncated, view full listing at source)