Senior QA Specialist

Senior Quality Assurance Specialist – Molecular Diagnostics (On-site Irvine, CA)

Rapidly growing diagnostics organization seeking a Senior QA Specialist to support and enhance a regulated Quality Management System for IVD and RUO products. This role partners cross-functionally with R&D, Manufacturing, Regulatory, and Operations to drive compliance, risk management, and continuous improvement.

Ideal candidates bring hands-on experience with FDA 21 CFR 820, ISO 13485, CAPA/complaints, supplier quality, audits, and eQMS platforms (e.g., MasterControl, Greenlight Guru). Background in molecular diagnostics, PCR, or regulated medical devices strongly preferred.

On-site role with strong growth potential, competitive compensation, and the opportunity to support innovative diagnostic technologies with real patient impact.