batch-release jobs in San Diego

Quality Assurance Specialist II leads and supports audit activities, serves as a QA subject matter expert during inspections, and manages quality events and risk assessments for medical device products. The role involves conducting root cause analyses, managing document control and training workflows, coordinating the internal audit program, and driving quality-system improvement projects.…See more The position requires a bachelor's degree in a scientific or engineering discipline with 3–5 years of QA or regulatory affairs experience in a regulated industry, with medical device experience highly preferred. Key responsibilities include compliance with ISO 13485 and 21 CFR Part 820, partnership with senior quality engineers on risk management, and eQMS implementation and validation.

The Quality Assurance Specialist II independently owns and operates defined Quality Management System processes, serving as a subject matter expert for batch release, NCMR/deviation/CAPA management, and asset control. The role requires judicious decision-making on routine and moderately complex quality and compliance matters, including investigating quality events, driving corrective actions, and supporting regulatory submissions and FDA inspections.…See more The specialist works collaboratively with a QA Associate and Sr. Quality Systems Engineer, leading process improvements and providing escalation support with minimal oversight.