BillionToOne

4 weeks ago

Quality Engineer, Prenatal

✓ Verified Job

Canonical indexed version, validated from employer's careers page.

Source: Company careers pageValidated by: Fursa AI

Last checked: 4 hours agoStatus: Live

Job Summary

Join BillionToOne as a Quality Engineer in Prenatal Lab Operations. You will lead quality management systems, collaborate with Lab Operations, Bioinformatics, Software Engineering, and R&D to drive process improvements in an LDT environment, manage nonconformances, CAPAs, deviations, and complaints, and ensure compliance with CLIA, CAP, NYSDOH, FDA/ISO. This onsite role focuses on data-driven quality improvements from requirements to go-live and continuous improvement.

Location: United States

Workplace: Onsite

Employment Type: Full time

Job Function: QA, Test & Release Engineering

Key Responsibilities

•Collaborate with cross-functional teams (laboratory operations, customer support, bioinformatics, software engineering, and assay development) to monitor operations, investigate issues, implement changes, and identify improvements.
•Drive occurrence management activities with cross-functional leads, including Nonconformances, CAPAs, Deviations, and Complaints.
•Develop, implement, maintain, and monitor quality assurance programs and systems to ensure compliance with regulatory requirements (CLIA, CAP, NYSDOH, etc.).
•Provide hands-on training and mentorship on quality processes, procedures, tools, and best practices to laboratory staff and cross-functional personnel.
•Review technical requirements, design specifications, risk management, validation/verification protocols and reports as part of laboratory operations, change control, and new product development.

Pay and Benefits

Perks:Health Insurance401kPaid ParentalMeal AllowanceEv Charging

Key Requirements

•Bachelor's degree in a scientific or technical field.
•Minimum of 5 years of experience within the LDT industry and familiarity with 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.
•Strong project management skills with a track record of driving cross-functional initiatives to completion.

Experience:5+ yearsGenomicsHealthcareBiotech

Education:Bachelor's

Skills:CommunicationLeadershipProblem-solvingMentoringCross-functional collaboration

Languages:English

Tech Stack:TableauArenaMedialabLeanSix Sigma

Company Brief

BillionToOne

Develops molecular counting and sequencing technologies for precise genetic testing. Offers noninvasive prenatal tests and rare disease genomic assays to improve detection accuracy and reduce false positives for clinical and commercial labs.

Industry: Diagnostics

Company Size: Medium (51 to 250 employees)

Growth: Growth Stage Startup

Headquarters: Redwood City, United States

Founded: 2016

Website LinkedIn

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BillionToOne

4 weeks ago

Quality Engineer, Prenatal

✓ Verified Job

Canonical indexed version, validated from employer's careers page.

Source: Company careers pageValidated by: Fursa AI

Last checked: 4 hours agoStatus: Live

Job Summary

Location: United States

Workplace: Onsite

Employment Type: Full time

Job Function: QA, Test & Release Engineering

Key Responsibilities

•Collaborate with cross-functional teams (laboratory operations, customer support, bioinformatics, software engineering, and assay development) to monitor operations, investigate issues, implement changes, and identify improvements.
•Drive occurrence management activities with cross-functional leads, including Nonconformances, CAPAs, Deviations, and Complaints.
•Develop, implement, maintain, and monitor quality assurance programs and systems to ensure compliance with regulatory requirements (CLIA, CAP, NYSDOH, etc.).
•Provide hands-on training and mentorship on quality processes, procedures, tools, and best practices to laboratory staff and cross-functional personnel.
•Review technical requirements, design specifications, risk management, validation/verification protocols and reports as part of laboratory operations, change control, and new product development.

Pay and Benefits

Perks:Health Insurance401kPaid ParentalMeal AllowanceEv Charging

Key Requirements

•Bachelor's degree in a scientific or technical field.
•Minimum of 5 years of experience within the LDT industry and familiarity with 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.
•Strong project management skills with a track record of driving cross-functional initiatives to completion.

Experience:5+ yearsGenomicsHealthcareBiotech

Education:Bachelor's

Skills:CommunicationLeadershipProblem-solvingMentoringCross-functional collaboration

Languages:English

Tech Stack:TableauArenaMedialabLeanSix Sigma

Company Brief

BillionToOne

Industry: Diagnostics

Company Size: Medium (51 to 250 employees)

Growth: Growth Stage Startup

Headquarters: Redwood City, United States

Founded: 2016

Website LinkedIn