Engineer II, Quality Complaint Management

Role: Engineer II, Quality Complaint Management at Axogen, overseeing complaint system processes for medical devices. Responsibilities: serve as principal complaint investigator, manage complaint trending, report and escalate issues, draft and submit regulatory reports (HHEAs, FARs, MDRs), support FDA interactions, coordinate adverse event assessments, revise controlled documents, train personnel, and support regulatory inspections. Requirements: Bachelor’s in a scientific/medical discipline, minimum 2 years’ experience in pharma or med device industry, with at least one year managing complaints compliant with 21 CFR and international standards. Skills: strong communication, organization, risk assessment per ISO 14971 and ICH Q9, independent decision-making. Preferred: experience managing complaint systems in regulated environments, familiarity with pharmacovigilance. High-Value: medical device focus, complaint management, regulatory reporting, FDA interaction, and GxP compliance. Work Setup: remote or onsite in Florida; salary range $69,333–$86,666, with benefits and bonus.