Sr Quality Engineer
Core
Coordinates quality investigations, design control, and regulatory compliance for manufacturing plants, focusing on root cause analysis and product release.
Role type
Senior Quality Engineer (Manufacturing)
Builds
Production quality systems and compliant product releases
Domain
Healthcare manufacturing / Quality Engineering
Deliverable
production ML models | product features | dashboards & analysis | research | client delivery | infrastructure | physical/clinical work
Required skills
Root cause analysis, Statistical analysis (DOE, regression, CpK), Risk management (FMEA, HACCP), Protocol design and execution, CAPA management, Supplier quality management, Technical report writing, Gage R&R studies
Preferred skills
Advanced degree, Mentorship of junior staff, Audit participation
Technologies
Microsoft Office, Statistical software
Responsibilities
Coordinate timely investigations within the manufacturing plant, Compose and execute design and process verification protocols, Investigate root cause solutions via NCR and CAPA, Ensure compliance with state and Federal regulations, Analyze CAPA trends and quality data, Provide direction and training on quality procedures
Seniority
Senior, hands-on IC