Quality Engineer
Core
Ensure product quality and manufacturing process compliance through inspection, statistical analysis, and corrective actions.
Role type
Quality Engineer
Builds
Inspection plans, PFMEA's, Control Plans, Statistical Process Control programs
Domain
Medical device manufacturing / Quality Engineering
Required skills
Statistical Process Control (SPC), Measurement System Analysis (Gage R&R), Process Capability Analysis, Design of Experiments, PFMEA, Control Plans, Validation activities, Lean Manufacturing, ISO 13485, FDA QSR 21CFR part 820
Preferred skills
Six Sigma, 3+ years in quality engineering
Technologies
Statistical tools, Inspection equipment
Responsibilities
Create inspection plans, Develop and maintain Statistical Process Control programs, Perform Gage R&R studies, Facilitate Corrective and Preventative Actions, Participate in Material Review Board and New Product Release Review, Perform process capability analysis, Conduct Vendor and Customer Audits, Write and update Work Instructions, Train employees
Seniority
Mid-level, hands-on IC