Quality Engineer II
Core
Initiates, implements, and manages the master validation plan to improve operational effectiveness and optimize validations for new products and machines.
Role type
Quality Engineer (Manufacturing/Validation)
Builds
Validated equipment, processes, software, and packaging systems for healthcare partners
Domain
Healthcare manufacturing / Medical devices
Required skills
Engineering methodologies, statistical analysis, design of experiments, risk analysis, change control management, KPI improvement, data analysis
Preferred skills
Lean Manufacturing, Green/Black Belt, ISO 13485 knowledge, sterilization validation, Minitab
Technologies
SAP, Minitab, Excel, Word
Responsibilities
Create and manage Master Validation Plan, conduct validation/qualification tests, perform sterilization validations, develop aging studies for packaging, lead Risk Analysis, improve production floor KPIs, act as SME for Change Control
Seniority
Mid-level, hands-on IC
