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.… 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.