Associate Specialist, Product Surveillance, ARC

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. This is a hybrid role that requires being on-site in Madison, WI two days per week. Responsibilities Key contributor as part of a complaint handling unit. Develop and implement methods and procedures for effective trending of complaints. Facilitate complaint investigation. Engage product design owners to determine effective CAPA. Identify complaints that represent further evaluation under 21CFR Part 803 (MDR). Review appropriate criteria for closure of complaints. Own and communicate metrics on status. Continuously improve the process. Quality Goals Comply with GEHC Quality Manual, Quality Management System, quality policies and applicable laws and regulations. Complete all planned Quality & Compliance training within deadlines. Identify and report quality or compliance concerns and take immediate corrective action. Identify and report compliance gaps related to QSR and CGMP requirements. Ensure zero repeat findings from previous internal and external audits within area of responsibility. Provide timely complaint handling and reporting. Provide objective evidence of complaint handling process through compliant documentation. Qualifications Bachelor’s degree from an accredited university or college. Or high school diploma / GED with at least 2 years experience in Quality or Regulatory Assurance or Engineering. Desired Characteristics Product specific knowledge in anesthesia machine and ICU ventilator devices. Knowledge of Quality Management System tools, continuous improvement methodologies and deep understanding of site-level products and processes. Expertise to effectively communicate within all levels of the organization about design controls, design verification and validation, production and process controls, corrective and preventive action, complaints, risk management and product quality improvement using tools such as Six Sigma, DFR, etc. Knowledge of 21CFR Part 820. Experience prioritizing conflicting demands in an extremely fast‑paced environment. Ability to analyze and process data and draw appropriate conclusions. Experience working with cross‑functional teams and facilitating identification and implementation of solutions to complex problems. Experience with Microsoft Office products. Additional Information GE HealthCare will not sponsor individuals for employment visas, now or in the future. Relocation assistance: No. GE HealthCare is an Equal Opportunity Employer. Employment decisions are made without regard to race, color, religion, national or ethnic origin, sex, sexual orientation, gender identity or expression, age, disability, protected veteran status or other characteristics protected by law. This position requires legal authorization to work in the United States. A drug screen may be required. #J-18808-Ljbffr