Sr Engineer QA
Core
Lead product design evaluation, process quality improvement, and supplier quality management for medical device manufacturing.
Role type
Senior Quality Assurance Engineer (Manufacturing/Supply Chain)
Builds
Production/quality processes, supplier quality controls, CAPA/SCAR management systems
Domain
Medical device manufacturing / Quality Assurance
Deliverable
production ML models | product features | dashboards & analysis | research | client delivery | infrastructure | physical/clinical work
Required skills
Supplier audit and assessment, Root cause analysis, CAPA and SCAR management, Validation document review, Design control file review, Process quality monitoring, Data analysis, Regulatory compliance knowledge, Recall investigation leadership, Cross-functional coordination
Preferred skills
Knowledge sharing and team development, Onsite validation execution
Technologies
None stated
Responsibilities
Analyze and evaluate product design for performance opportunities, Coordinate with US quality/R&D teams for continuous improvement projects, Work with suppliers to optimize production/quality processes, Conduct supplier audits and manage critical findings, Resolve root causes of quality issues and lead recall investigations, Execute CAPA & SCAR management, Support design control file and design transfer reviews, Organize knowledge sharing sessions, Conduct onsite validation activities, Support other divisions with quality/manufacturing expertise
Seniority
Senior, hands-on IC
