Quality Engineer II

Quality Engineer II supports manufacturing operations in Abbott’s Heart Failure division by providing quality engineering oversight, investigations, and continuous-improvement initiatives. Responsibilities include supporting production activities to ensure compliance with procedures and regulatory requirements, leading investigations of complaints, nonconforming material, deviations, and quality events; contributing to CAPA activities with root cause analysis and effectiveness verification; performing risk assessments and quality impact evaluations; identifying opportunities to improve product quality, process performance, and operational efficiency using quality tools and statistical methods; and collaborating cross-functionally with Manufacturing, Operations, Engineering, R&D, Regulatory Affairs, and Supply Chain while ensuring compliance with FDA, ISO 13485, MDR, and company quality system requirements. The role requires a bachelor’s degree (or master’s with relevant experience) and experience in a regulated industry; preferred qualifications include medical device sector experience and ASQ CQE certification.