The Quality Engineer II is responsible for ensuring product quality, process compliance, and effective execution of Quality Management System (QMS) requirements throughout the product lifecycle. This role partners with Manufacturing, Engineering, R&D, Regulatory Affairs, Quality Control, and Supply Chain teams to investigate quality issues, execute CAPAs, support risk management activities, maintain regulatory compliance, and drive continuous improvement initiatives. The position requires strong analytical skills, root cause investigation experience, and knowledge of regulated manufacturing environments such as medical devices, biotechnology, diagnostics, or pharmaceuticals.
