Quality Engineer II
Core
Investigate root causes of quality defects, analyze data for process improvements, and recommend corrective actions to manufacturing and engineering teams.
Role type
Quality Engineer II
Builds
Production quality improvements and defect resolution
Domain
Medical device manufacturing / Quality Engineering
Deliverable
production ML models | product features | dashboards & analysis | research | client delivery | infrastructure | physical/clinical work
Required skills
Root cause analysis, Statistical analysis (Correlation, regression, DOE), Gage R&R studies, Technical report writing, Data analysis, Lean manufacturing principles, Process validation, Risk management (FMEA, HACCP)
Preferred skills
Injection molding experience, Polymer processing knowledge, Lean Six Sigma tools
Technologies
Microsoft Office, Statistical software, Gage R&R tools
Responsibilities
Investigate root cause solutions for product release via NCR/CAPA/MCH/ALH, Analyze reports and data for in-house process improvements, Support departments with product quality inspections and non-conforming product disposition, Recommend measures to prevent defect recurrence, Conduct engineering studies and feasibility reports, Perform receiving and first article inspections, Decontaminate and inspect equipment in bio-safety cabinets
Seniority
Mid-level, hands-on IC