More jobs:
Senior QA Specialist
Job in
Irvine, Orange County, California, 92713, USA
Listed on 2025-12-27
Listing for:
Connexis Search Group
Full Time
position Listed on 2025-12-27
Job specializations:
-
Healthcare
Data Scientist -
Quality Assurance - QA/QC
Data Analyst
Job Description & How to Apply Below
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.
- 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.
- 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.
to apply online
#J-18808-LjbffrPosition Requirements
10+ Years
work experience
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