About the job
About the Role:
As a Senior Quality Assurance Engineer at 10xgenomics, you will spearhead efforts to evaluate, develop, and improve both product and supplier quality. Your strong analytical, technical, and collaborative skills, complemented by your extensive experience in quality assurance for complex instruments, will enable you to establish robust quality strategies, cultivate solid supplier relationships, and guarantee that the highest quality standards are consistently met across products and the supply chain.
What You'll Be Doing:
New Product Transfer
- Work closely with R&D and Engineering teams to ensure products satisfy quality, manufacturability, and reliability standards from pilot builds through to production.
- Provide quality oversight and guidance to internal teams and contract manufacturers throughout the new product introduction and production transfer phases.
- Engage in build readiness reviews, risk assessments, and issue resolution to facilitate a smooth transition from pilot production to full-scale manufacturing.
Supplier Quality Management
- Collaborate with contract manufacturers and key suppliers to ensure that product and process quality aligns with company requirements.
- Evaluate, develop, and continuously enhance supplier quality systems, striving for alignment with company expectations and quality standards (ISO 9001/13485).
- Execute supplier audits, process reviews, and performance monitoring utilizing quality metrics and KPIs.
- Lead root cause analysis and corrective action implementation for supplier-related issues, including SCAR management.
- Forge strong collaborative relationships with suppliers to promote a culture of quality ownership and continuous improvement.
Manage Quality Operations
- Oversee the investigation and resolution of nonconformances, deviations, and manufacturing issues reported by internal production teams.
- Collaborate with contract manufacturers and suppliers regarding failure analysis and corrective actions.
- Support customer complaint investigations related to instruments, ensuring prompt containment, root cause identification, and CAPA implementation.
- Drive ongoing quality improvements in instrument assembly processes, both in-house and at supplier locations.
Continuous Improvement
- Assist in the development and continuous enhancement of quality procedures, documentation, and control processes.
- Monitor and analyze key quality metrics to identify trends and implement preventive actions.
- Facilitate internal and external audits, qualification, and regulatory compliance activities.

