Quality Associate 2

Personalisinc

Fremont, CA, United States
Base: $85,000 to $95,000 py; bonus/equity: annual ...
On-site (tuesday - saturday, 9:30am - 6pm)
Quality management system
Clia, cap, iso 15189, iso 13485, 21 cfr 820
Gcp / gclp compliance
Personalis is seeking a Quality Associate 2 to join their team in Fremont, CA, focusing on the implementation and management of their Quality Management System in a regulated environment. The ideal candidate will have experience in quality roles within the biotech or medical device sectors and be ready to work an offset schedule from Tuesday to Saturday

Job Summary

  • Assist in the implementation and management of the Quality Management System in accordance with CLIA, CAP, ISO 15189, ISO 13485, 21 CFR 820 and other regulations.
  • Perform timely quality review and audits of Clinical Study data in compliance with GCP / GCLP to ensure accuracy, consistency, and traceability.
  • Initiate and investigate nonconformances/deviations, assist in root cause analysis for CAPAs, and help drive continuous improvement initiatives.

Matching Summary

Match Score: 85

Personalis is seeking a Quality Associate 2 to join their team in Fremont, CA, focusing on the implementation and management of their Quality Management System in a regulated environment. The ideal candidate will have experience in quality roles within the biotech or medical device sectors and be ready to work an offset schedule from Tuesday to Saturday.

Salary

Base: $85,000 to $95,000 per year; Bonus/Equity: annual performance-based bonus; Benefits: Not specified

Skills & Requirements

Must-have

  • Quality Management System
  • CLIA, CAP, ISO 15189, ISO 13485, 21 CFR 820
  • GCP / GCLP compliance
  • ALCOA+ principles
  • laboratory data auditing
  • SOP authorship
  • CAPA, Lean, 5 Why's, Pareto Analysis

Nice-to-have

  • continuous improvement initiatives
  • high-energy, hands-on environment
  • electronic document management systems

Key Requirements

  • Bachelor's degree
  • 3-5 years in a Quality role
  • medical device or biotech industry experience
  • ISO Standards and FDA-regulated environment experience highly desirable

Work Rights

Not specified

Tailored Resume

Cover Letter