Associate Specialist, Product Surveillance, ARC
GE HealthCare · Madison, Wisconsin, US
Job Description Summary Manages complaint handling activities and supports key Quality & Regulatory areas to ensure safe and effective products in the instal...
Job description
Job Description Summary Manages complaint handling activities and supports key Quality & Regulatory areas to ensure safe and effective products in the install base across GE Healthcare Developing conceptual knowledge of professional discipline. May include support roles with specialized expertise or technical knowledge in broad area. This is a hybrid role that requires being on-site in Madison, WI two days per week. GE HealthCare is a leading global medical technology and digital solutions innovator. Our mission is to improve lives in the moments that matter. Unlock your ambition, turn ideas into world-changing realities, and join an organization where every voice makes a difference, and every difference builds a healthier world. Job Description: Roles and Responsibilities: Key contributor as part of a complaint handling unit. Developing and implementing methods and procedures for effective trending of complaints. Facilitating complaint investigation. Engaging product design owners to determine effective CAPA. Identifying complaints that represent further evaluation under 21CFR Part 803 (MDR). Reviewing appropriate criteria for closure of complaints. Owning and communicating metric...