Job Description
Insight Global is seeking a Senior Quality Engineer to support a leading medical device manufacturer specializing in combination medical devices. This newly created role is focused on establishing a best‑in‑class approach to drug–device combination products, integrating pharmaceutical science, quality systems, and manufacturing execution. This role partners closely with Operations and Product Development teams to ensure compliance with current Good Manufacturing Practices (cGMP) and 21 CFR Part 4 requirements for drug-device combination products manufactured in the Urology business. The individual will lead quality and continuous improvement initiatives, serve as the technical quality lead during audits, analyze quality data and manufacturing metrics to identify trends and drive corrective actions, and collaborate with cross-functional teams to reduce defects, nonconformances, and customer complaints. Responsibilities also include developing quality plans, specificat...