Connexis Search Group
Overview
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.
Responsibilities
Support and enhance the regulated Quality Management System for IVD and RUO products.
Partner cross-functionally with R&D, Manufacturing, Regulatory, and Operations to drive compliance and risk management.
Lead continuous improvement initiatives within the Quality Management System.
Qualifications
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.
Strong communication and cross‑functional collaboration skills.
On‑site role with strong growth potential, competitive compensation, and the opportunity to support innovative diagnostic technologies with real patient impact.
Click here to apply online
#J-18808-Ljbffr
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.
Responsibilities
Support and enhance the regulated Quality Management System for IVD and RUO products.
Partner cross-functionally with R&D, Manufacturing, Regulatory, and Operations to drive compliance and risk management.
Lead continuous improvement initiatives within the Quality Management System.
Qualifications
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.
Strong communication and cross‑functional collaboration skills.
On‑site role with strong growth potential, competitive compensation, and the opportunity to support innovative diagnostic technologies with real patient impact.
Click here to apply online
#J-18808-Ljbffr