Overview
QA Specialist Jobs in Irvine, USA at Connexis Search Group
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., Master Control, 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.
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Title: QA Specialist
Company: Connexis Search Group
Location: Irvine, USA
Category:
