QA & Regulatory CAPA Lead

Personalis, Inc.; Fremont (CA); Hybrid; USD 160,000 - 220,000; Full time

Job summary

Personalis, Inc. in Fremont, California, seeks a Sr. Manager/ Associate Director for Nonconformance & CAPA Management to own NC, CAPA, PD, and Quality Investigation programs across the enterprise.

The role ensures strict compliance with FDA 21 CFR Part 820, ISO 13485:2016, CLIA/CAP, and global IVD requirements, driving proactive prevention through data-driven oversight. This position reports to the Sr. Director of Quality Assurance and collaborates with Clinical Laboratory Operations, Assay

Qualifications

• 8–10+ years in QA/Quality Systems in FDA-regulated IVD/medical device environments.
• At least 4+ years in formal program management or leadership roles.
• Strong knowledge of 21 CFR Part 820, ISO 13485:2016.
• Familiarity with CLIA, CAP, NYS CLEP, and EU IVDR is highly preferred.

Responsibilities

• Provide end-to-end governance for NC, CAPA, PD, and QC investigations.
• Chair CAPA & QRB; drive robust root-cause analyses and risk-based prioritization.
• Oversee investigation lifecycle with structured problem-solving methods (5-Why, Ishikawa, DMAIC).
• Establish Verification/Effectiveness Checks to prevent recurrence and protect device safety.
• Present governance dashboards and metrics to Management Review and Quality Exec Committee.

Skills

Quality Assurance

Quality Systems

Program management

Leadership

Regulatory knowledge

Risk management

Tools

eQMS

Job description

Personalis, Inc. in Fremont, California, seeks a Sr. Manager/ Associate Director for Nonconformance & CAPA Management to own NC, CAPA, PD, and Quality Investigation programs across the enterprise.

The role ensures strict compliance with FDA 21 CFR Part 820, ISO 13485:2016, CLIA/CAP, and global IVD requirements, driving proactive prevention through data-driven oversight. This position reports to the Sr. Director of Quality Assurance and collaborates with Clinical Laboratory Operations, Assay