Quality Engineer (Complaint Handling) - Duncan, SC
Core
Manage product failure/non-conformance, CAPA, and complaint processes while driving quality adherence and risk assessment in high-volume manufacturing.
Role type
Quality Engineer (Complaint Handling)
Builds
Quality assurance processes and continuous improvement initiatives for life sciences manufacturing
Domain
Life sciences, diagnostics, biotechnology manufacturing
Required skills
root cause analysis, CAPA management, risk assessment, process validation, change control, data analysis, Lean manufacturing principles, cross-functional collaboration, conflict resolution
Preferred skills
Lean Six Sigma, Veeva, SAP, Magic (Enovia), technical writing
Responsibilities
Manage product failure/non-conformance, CAPA and Complaint processes; complete root cause analysis and implement action plans; verify CAPA closures; provide manufacturing quality trend charts/analysis; suggest/implement continuous improvement practices and kaizen events; work with cross-functional teams (engineering, quality, manufacturing, customer service)
Seniority
Mid-level, hands-on IC