Senior Product Complaint Analyst

Responsible for adherence to Good Manufacturing Practices (GMPs) and proper complaint handling per the Code of Federal Register (CFR) and other governmental regulations. Your responsibilities will include: Applying clinical knowledge to review complaint communications and laboratory analysis to apply event coding, assess for regulatory compliance reportability, and potential impact to patient safety and business operations. Performs quality review and approval of records to ensure accuracy and compliance. Works independently guided by company policies, guidelines and procedures, receiving guidance on complex and unprecedented problems. Participate in onboarding, training, and continuous improvement initiatives. Provide constructive guidance and coaching to new or less experienced analysts, providing actionable feedback that supports skill development and builds confidence. Bachelor's degree, or an equivalent combination of education and experience in lieu of a degree Minimum of 5 years of experience in medical device complaint processing and reporting College Degree focus in Biology, Health Sciences, Biotechnology or Engineering preferred Self‑motivated, goal‑driven, and results‑oriented team player Strong written and verbal communication skills Excellent time management and organizational abilities Experience with SAS, PowerBI, or TrackWise applications Experience reviewing scientific literature