Site Quality Lead/Site Engineer - QA
Core
Lead quality assurance practices, process control, and corrective actions for a microbiology manufacturing site.
Role type
Site Quality Lead / Site Engineer
Builds
Microbiology products and services
Domain
Life Sciences / Medical Device Manufacturing
Deliverable
production ML models | product features | dashboards & analysis | research | client delivery | infrastructure | physical/clinical work
Required skills
GMP compliance, root cause analysis, change control management, process improvement methodologies, regulatory reporting, cross-functional collaboration
Preferred skills
Lean manufacturing, Six Sigma (Green/Black Belt), FMEA, SPC, DOE, Power BI, Mini-tab
Technologies
Power BI, Mini-tab
Responsibilities
Lead investigations, deviations, and change controls; Partner with Operations to establish inspection points; Drive customer complaint resolution; Facilitate Kaizen events and continuous improvement; Report to regulatory agencies; Analyze trends and lead corrective actions.
Seniority
Mid-level, hands-on IC
