Quality Engineer, Prenatal

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.

Requirements

• 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.
• 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:

Benefits

Additional Information

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. In this role you will be responsible for identifying, developing, and executing process improvements and will work closely with cross-functional stakeholders across BillionToOne (e.g. Lab Operations, Bioinformatics, Process Engineering, Software Engineering, R&D). You will lead the analysis of data to identify improvement initiatives and will execute those process improvements from initial 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.

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