Lead or support Product Quality Signal (PQS) assessments, Health Hazard Evaluation Determinations (HHEDs), Health Hazard Evaluations (HHEs), Issue Evaluations (IEs), Nonconformance Reports (NCRs), deviations, CAPAs, root cause investigations, and other Quality System activities, including appropriate interface with product risk management processes. Comprehensive knowledge of FDA QMSR, ISO 13485, document control, records management, training systems, PQS, HHED/HHE, IE, NCR/deviation, CAPA, audits, risk management, and change control.