BillionToOne
Quality Engineer, Prenatal
Union City, CA
Sponsorship not specified$123k-$134kDetected 14 hours ago
Data VisualizationProject ManagementAgileAuditingProcess ImprovementCustomer SupportUnityFDA RegulatoryBioinformaticsMedical DevicesCollaborationMentoringPublic SpeakingInternal Audit
About the role
- A Rare Opportunity to Shape the Future of Genomics Join a team of brilliant, passionate innovators determined to transform healthcare.
- 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.
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.).
- Support the internal audit program and other continuous improvement processes.
- 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.
- 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.
- Expertise in Quality Improvement such as Lean, Six Sigma, and Root Cause Analysis.
- 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).
- 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.
- Comfortable navigating ambiguity and shifting priorities in a high-growth environment using proactive and creative thinking to make meaningful contributions.
- 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 Product Quality such as Design Control, Risk Management, and Usability.
Skills
- A Rare Opportunity to Shape the Future of Genomics
Compensation
- 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.
Benefits
- 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
- A variety of perks on campus (state of the art gym, restaurant)
- We do not discriminate on the basis of race, religion, color, national origin, gender, sexual orientation, age, marital status, veteran status, or disability status.
Company info
- 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.
Equal opportunity
- equal opportunity employer.
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