Quality Engineer II
Core
Initiates, implements, and manages master validation plans for new products, equipment, processes, and software in a manufacturing environment.
Role type
Quality Engineer (Manufacturing)
Builds
Validated medical device products and manufacturing processes
Domain
Healthcare / Medical Devices / Manufacturing
Deliverable
production ML models | product features | dashboards & analysis | research | client delivery | infrastructure | physical/clinical work
Required skills
Master Validation Plan management, Design of Experiments (DOE), Statistical analysis, Sterilization validation, Risk Analysis, Change Control, KPI improvement, Data analysis
Preferred skills
Lean Manufacturing, Six Sigma (Green/Black Belt), Medical Device regulations (ISO 13485), Minitab
Technologies
SAP, Minitab, Excel, Word
Responsibilities
Create and manage Master Validation Plan; Conduct validation/qualification tests on equipment and processes; Conduct sterilization validations; Develop and manage aging studies for packaging; Lead Risk Analysis; Improve production floor KPIs; Act as SME for Change Control
Seniority
Mid-level IC (4-6 years experience)
