Sr. Engineer, Quality Complaint Management

Role: Senior Engineer in Quality Complaint Management, responsible for overseeing the complaint system for medical devices and biologics at Axogen. Key responsibilities include leading tissue and biologics complaint investigations, managing regulatory reporting such as MDRs and FARs, and coordinating with cross-functional teams to ensure timely complaint assessment and reporting. The position involves monitoring complaint system performance, conducting risk assessments in accordance with ISO 14971 and ICH Q9, and supporting regulatory and inspection activities. Requirements: Bachelor's in a scientific or medical discipline; at least five years’ experience in pharmaceutical or medical device industries, with specific experience in complaint management and regulatory compliance (21 CFR 211, 600, 820, 1271). Preferred skills include strong interpersonal, communication, organizational, and decision-making abilities, along with knowledge of FDA interactions and risk management principles. High-value specifics: focus on tissue and biologics, regulatory compliance, complaint system oversight, and FDA interactions. Work setup: remote or in-office in Florida, with salary range $84,190–$105,237 USD, and eligibility for an annual bonus.