Sr. QA Specialist

A growing in vitro diagnostics organization in the Irvine, CA area is seeking a senior quality assurance professional to support and strengthen its quality management system for regulated diagnostic products. This fully onsite role partners across research and development, manufacturing, regulatory affairs, and operations to maintain compliance and improve product and process quality.

The position leads internal audit and CAPA activities, supports supplier quality and SCAR processes, and provides quality oversight across design controls, risk management, validation, and product lifecycle activities. Qualified candidates will have a bachelor’s degree or higher in a relevant life science or engineering field, quality assurance experience in the medical device or IVD industry, knowledge of ISO 13485, ISO 14971, and FDA 21 CFR 820/QMSR, and hands-on eQMS experience.