Quality Engineer, Prenatal

BillionToOne•Union City, CA

5d•Onsite

About The Position

BillionToOne is a publicly traded company on Nasdaq focused on transforming healthcare through life-changing diagnostics. They are seeking a Quality Engineer, Prenatal Lab Operations with a strong background in the LDT environment, lab practices, bioinformatics, report automation, assays, and reagents. The role involves identifying, developing, and executing process improvements, collaborating with cross-functional teams, and ensuring compliance with regulatory requirements. This is an onsite position in Union City, CA, reporting to the Quality Manager, Prenatal.

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.

Nice To Haves

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.

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.

Benefits

Working alongside brilliant, kind, passionate and dedicated colleagues, in an empowering environment, toward a global vision, striving for a future in which transformative molecular diagnostics can help millions of patients
Open, transparent culture that includes weekly Town Hall meetings
The ability to indirectly or directly change the lives of hundreds of thousands patients
Multiple medical benefit options; employee premiums paid 100% of select plans, dependents covered up to 80%
Extremely generous Family Bonding Leave for eligible employees (16 weeks, paid at 100%)
Supplemental fertility benefits coverage
Retirement savings program including a 4% Company match
Increase paid time off with increased tenure
Latest and greatest hardware (laptop, lab equipment, facilities)
Free daily on-site lunches provided from top eateries
A variety of perks on campus (state of the art gym, restaurant)
Free on-site EV charging (compatible with all EVs, including Tesla)
Base pay range ($123,262 - $133,981 per year)
Generous equity options offering
Corporate bonus program
Industry leading company benefits (free healthcare options, 401k match, very generous fully paid parental leave, etc.)