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.
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.
Qualifications:- 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.
Benefits And Perks:- 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)
At BillionToOne, we are proud to offer a combination of a (1) base pay range (actual amount offered is based on experience and salary/equity options split that the candidate chooses), (2) generous equity options offering, (3) corporate bonus program, on top of (4) industry leading company benefits (free healthcare options, 401k match, very generous fully paid parental leave, etc.).
For this position, we offer a total compensation package of $172,379 per year, including a base pay range of $123,262 - $133,981 per year.
