Sr. Quality Assurance Engineer
Core
Senior Quality Engineer ensuring compliance with GMP and regulatory requirements in a regulated medical device manufacturing environment.
Role type
Senior Quality Engineer (Medical Devices)
Builds
Medical devices (Continuous Glucose Monitoring systems)
Domain
Healthcare / Medical Device Manufacturing
Deliverable
client delivery
Required skills
GMP compliance, Lot Release, sterilization processes, CAPA management, risk management (FMEA), internal auditing, statistical analysis, process validation, quality metrics monitoring
Preferred skills
Six Sigma, MiniTab, continuous improvement initiatives
Technologies
Microsoft Office, database applications, MiniTab
Responsibilities
Oversee quality activities supporting daily manufacturing, lead investigations for non-conformances, plan and manage compliance of manufacturing processes, perform risk management activities, conduct internal audits, analyze production data to identify trends, design methods for inspecting and testing production processes
Seniority
Senior, hands-on IC