Continuous Improvement Quality Engineer (CIQE)
Core
Ensure quality systems, products, and manufacturing processes comply with standards (ISO 13485, 21CFR820) by driving improvements in Non-Conformance (NC) and Corrective and Preventive Action (CAPA) processes.
Role type
Senior IC Quality Engineer (Manufacturing/Regulated)
Builds
Closed-loop quality management systems and compliant manufacturing processes
Domain
Medical Devices / Regulated Manufacturing
Required skills
NC & CAPA process expertise, Root cause analysis, Quality system regulations (21CFR820, ISO 13485), cGMP documentation, Data analysis, Project management, Cross-functional collaboration
Preferred skills
ASQ certification (CQE/CQA), Lean/Six Sigma (Green/Black Belt), Enterprise business unit experience
Technologies
Microsoft Office, Electronic Quality Management Systems
Responsibilities
Lead and complete NC & CAPA projects, Investigate quality issues and perform preliminary analysis, Mentor junior team members on NC/CAPA processes, Support audits and inspections, Drive process improvements using Six Sigma methodologies
Seniority
Senior, hands-on IC