Sr Quality Assurance Engineer (Onsite - Acton,MA)

Job Summary The Senior Quality Assurance Engineer is responsible for ensuring the quality, safety, and regulatory compliance of medical device manufacturing processes while serving as a key quality representative for production operations. This role partners closely with manufacturing, engineering, operations, and quality teams to investigate nonconformances, lead root cause analyses, manage CAPAs, support process validations, and drive continuous improvement initiatives that ensure the consistent production of safe and effective medical devices. The position requires strong expertise in quality systems, risk management, statistical analysis, and regulatory standards such as FDA regulations, ISO 13485, and ISO 14971.…