Director of Quality
BillionToOne(2 years ago)
About this role
The Director of Quality will lead operational quality initiatives to support the company’s CLIA-certified laboratory operations, focusing on reducing nonconformances, improving inspection processes, and implementing supplier controls. This hands-on leader partners with Lab Operations, Supply Chain, R&D, and other stakeholders to embed quality into daily workflows, drive continuous improvement, and support regulatory inspection readiness. The role is onsite in Union City, CA and reports to the Vice President of QARA.
Required Skills
- Incident Management
- Material Management
- Supplier Management
- Root Cause Analysis
- Corrective Actions
- Process Optimization
- Cross-Functional Collaboration
- Investigations
- Trend Analysis
- Metrics Tracking
+5 more
Qualifications
- ISO 13485
- Six Sigma Green Belt
- Six Sigma Black Belt
About BillionToOne
billiontoone.comBillionToOne is a genomics diagnostics company focused on advancing disease detection, with primary emphasis on noninvasive prenatal screening and liquid biopsy. They use proprietary molecular counting technology to improve sensitivity for detecting rare genetic variants and low-frequency signals in cell-free DNA, enabling more accurate prenatal and oncology testing. BillionToOne develops and markets clinical assays and partners with healthcare providers and labs to bring those tests into clinical practice. The company is publicly traded on NASDAQ under the ticker BLLN.