Quality Engineer
Core
Ensure manufacturing quality and process capability for surgical products through inspection, validation, and statistical analysis.
Role type
Quality Engineer (Manufacturing)
Builds
Inspection plans, PFMEA's, Control Plans, Statistical Process Control programs
Domain
Medical Devices / Surgical Instruments / Manufacturing
Deliverable
production ML models | product features | dashboards & analysis | research | client delivery | infrastructure | physical/clinical work
Required skills
Statistical Process Control (SPC), Measurement System Analysis (Gage R&R), Process Capability Analysis, PFMEA, Control Plans, Validation activities, Design of Experiments, Lean Manufacturing, ISO 13485, FDA QSR 21CFR part 820
Preferred skills
Six Sigma, Supplier Quality Audits, Customer Specific Requirements implementation
Technologies
Statistical tools, Inspection equipment, PFMEA software
Responsibilities
Create inspection plans for new and existing products, Develop and maintain Statistical Process Control programs, Perform Gage R&R studies and process capability analysis, Facilitate Corrective and Preventative Actions, Participate in Material Review Board and New Product Release Review, Write and update work instructions, Perform Vendor and Customer Audits, Train employees on quality procedures
Seniority
Mid-level, hands-on IC
