Adanced Quality Engineer
Core
Analyzes defects, manages non-conformances, and drives Corrective and Preventive Actions (CAPA) to optimize operational performance and product quality in manufacturing.
Role type
Quality Engineer (Manufacturing)
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 | client delivery | infrastructure | physical/clinical work
Required skills
Root Cause Analysis (RCA), CAPA Methodologies, Process Quality Management, Statistical Analysis, Process Validation, Regulatory Compliance, Supplier Quality Management, Continuous Improvement, Technical Documentation, Manufacturing Processes
Preferred skills
Design for Quality (DFQ), Process Monitoring, Safety and Security Risk Assessment, Data Analysis & Interpretation
Responsibilities
Analyze defects and determine dispositions of non-conformances; Conduct impact assessments for Process Failure Mode and Effects Analysis (PFMEA); Support operations performance monitoring and risk assessment; Coordinate quality engineering tasks for New Product Introduction (NPI) and product transfers; Prepare and deliver quality metrics and reports to stakeholders; Participate in investigations and collaborate with suppliers and R&D to resolve quality issues.
Seniority
Mid-level, hands-on IC