Advanced Quality Engineer
Core
Analyzes defects, manages non-conformances, and drives Corrective and Preventive Actions (CAPA) to optimize operational performance and elevate product quality benchmarks in manufacturing.
Role type
Advanced Quality Engineer
Builds
Manufacturing quality systems, process validation protocols, and quality metrics for healthcare products.
Domain
Healthcare manufacturing / Quality Engineering
Deliverable
production ML models | product features | dashboards & analysis | infrastructure
Required skills
Root Cause Analysis (RCA), CAPA Methodologies, Process Quality Management, Advanced Statistical Analysis, Regulatory Requirements, Manufacturing Processes, Process Monitoring, Technical Documentation, Continuous Improvement, Design for Quality (DFQ)
Preferred skills
Supplier Quality Engineering, Risk Assessment, Process Engineering
Responsibilities
Analyze defects and determine dispositions of non-conformances; Conduct impact assessments for Process Failure Mode and Effects Analysis (PFMEA); Coordinate quality engineering tasks for New Product Introduction (NPI) and product transfers; Apply advanced statistical analysis to interpret complex data trends; Ensure execution of process validation protocols; Prepare and deliver quality metrics and reports to stakeholders; Collaborate with suppliers, R&D, and manufacturing teams to resolve quality issues.
Seniority
Mid-level, hands-on IC