Description

The Quality Specialist I is an entry-level quality assurance and compliance role that supports day-to-day quality system activities in a regulated environment. This individual plays a key role in ensuring that Noxilizer’s products, services, and operations meet internal quality standards and comply with applicable regulations, including ISO 13485, FDA 21 CFR Part 820, and other relevant industry guidelines. Responsibilities include assisting in the maintenance of the Quality Management System (QMS), supporting audits, performing reviews of batch records, participating in investigations, managing controlled documents, coordinating training, and monitoring quality metrics.

Requirements

Associate’s or Bachelor’s degree in Life Sciences, Biology, Chemistry, Engineering, or related field (required); 0–2 years of experience in a regulated environment; Understanding of basic quality principles, cGMP, ISO 13485, and/or FDA 21 CFR Part 820 (training will be provided); Strong attention to detail; Excellent written and verbal communication skills; Proficiency in Microsoft Office Suite.