QA CAPA Engineer II
Core
Facilitate investigation and CAPA processes to reduce customer complaints, identify root causes, and implement corrective/preventative actions for quality deviations.
Role type
Quality Engineer (CAPA & Investigation)
Builds
Quality improvements and compliance within regulated manufacturing environments
Domain
Life Sciences / Medical Devices / Regulated Manufacturing
Deliverable
client delivery
Required skills
Root cause analysis (RCA), CAPA implementation, statistical analysis, process deviation management, ISO 13485 knowledge, FDA cGMP regulations knowledge, Microsoft Office proficiency, data analysis
Preferred skills
Minitab, JMP, TrackWise CAPA Management System
Responsibilities
Provide quality support for issues requiring impact assessment and root cause analysis; Work directly with investigation teams on critical quality issues; Facilitate investigation activities related to process/product deviations; Implement corrective and preventative actions (CAPAs) and verify effectiveness; Perform statistical analysis to track report data; Contribute to continual process improvement via Kaizens and Gemba tours
Seniority
Mid-level IC