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
Deliverable
production ML models | product features | dashboards & analysis | research | client delivery | infrastructure | physical/clinical work
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