Senior Quality Engineer
Core
Establish, improve, and maintain the quality system for medical device manufacturing operations and products.
Role type
Senior Quality Engineer (Medical Devices)
Builds
High-quality medical devices and compliant manufacturing processes
Domain
Medical Devices / Manufacturing / Quality Assurance
Required skills
CAPA management, Root Cause Analysis, Risk Management, Audit execution, Supplier quality management, Lean Six Sigma, Statistical process control, Change management, Human Factor analysis, Validation/Qualification
Preferred skills
Regulatory agency interaction (FDA, MoH), Human Error Prevention principles, Multi-site team collaboration
Technologies
Microsoft Office Suite (Word, Excel, PowerPoint), MSA tools
Responsibilities
Manage internal and supplier-driven Non-Conformances (NCs), Lead Corrective and Preventive Actions (CAPAs), Review and approve change management activities, Interpret KPI trends for continuous improvement, Support product holds and containment plans, Manage supplier relationships and performance, Provide QA support during internal and external audits.
Seniority
Senior, hands-on IC