Process Quality Engineer
Core
Ensures high-quality performance, compliance, and continuous improvement for Image Guided Therapy Devices manufacturing.
Role type
Process Quality Engineer
Builds
Manufacturing quality systems and validated production processes for medical devices
Domain
Medical Device Manufacturing / Quality Engineering
Required skills
CAPA implementation, PFMEA, Root Cause Analysis, Risk Assessment (ISO 14971), Statistical Data Analysis, Supplier Quality Collaboration, Process Validation, NPI Support
Preferred skills
ASQ Certification, FDA-regulated environment experience
Technologies
ISO 14971, PFMEA, CAPA, Statistical Analysis Tools
Responsibilities
Analyze defects and manage Non-Conformances (NC) and Quality Notifications (QN), Execute process validation protocols, Coordinate New Product Introduction (NPI) and design transfers, Apply advanced statistical analysis to interpret data trends, Prepare quality metrics and reports for stakeholders, Collaborate with R&D and suppliers to resolve quality issues
Seniority
Entry to Mid-level, hands-on IC