Senior Engineer, Quality Process
Core
Analyze and resolve production issues, monitor process data, and drive continuous improvement for manufacturing processes and quality systems.
Role type
Senior Quality Engineer (Manufacturing)
Builds
Optimized production, inspection, and quality system processes
Domain
Medical device manufacturing / Quality Assurance
Required skills
Root cause analysis, CAPA management, Non-conformance disposition, Change management, KPI trend analysis, Manufacturing complaint analysis, Audit support, Human Factor practices, Risk management, Lean philosophy, Process validation, Measurement System Analysis (MSA), Supplier relationship management
Preferred skills
Med Device manufacturing processes, ISO 13485, GMP, Lean Six Sigma, Statistical sampling plans, Process Capability, Gauge R&R, Regulatory agency interaction (FDA, MoH, TUV)
Technologies
Microsoft Word, Microsoft Excel, Microsoft PowerPoint
Responsibilities
Collaborate cross-functionally to resolve quality issues, Manage internal and supplier-driven Non-Conformances, Own Corrective and Preventive Actions (CAPAs), Lead development and improvement of manufacturing processes, Review and approve change management activities, Interpret KPI trends and drive continuous improvement, Support execution and analysis of manufacturing complaints, Provide QA support during audits, Advocate Human Factor practices, Support process/equipment validation and MSA, Manage supplier relationships and performance
Seniority
Senior, hands-on IC