Senior Quality Engineer - Respiratory
Core
Setting quality standards, leading process validation, and managing supplier quality for medical device production.
Role type
Senior Quality Engineer (Medical Devices)
Builds
Production processes and compliant medical device products
Domain
Medical Devices / Manufacturing
Required skills
Statistical process control (SPC), Design control, Risk management, CAPA, Supplier quality management, Regulatory compliance (21 CFR 820, ISO13485), Experimental design, Data analysis
Preferred skills
Six Sigma/Lean concepts, Advanced Six Sigma/Lean concepts
Technologies
MS Office Suite, Excel (Pivot tables, reporting)
Responsibilities
Manage development of process control and validation methods; Design complex experiments to analyze process variation; Lead supplier qualifications and corrective actions; Ensure compliance with domestic and international regulations; Lead investigations of non-conformances and develop CAPA.
Seniority
Senior, hands-on IC