QA Engineer 2
Core
Designing, implementing, and maintaining quality assurance protocols for manufacturing and production processes of medical devices.
Role type
Manufacturing Quality Assurance Engineer
Builds
Medical device production processes and finished products
Domain
Medical Devices / Biosensing Technology
Deliverable
production ML models | product features | dashboards & analysis | research | client delivery | infrastructure | physical/clinical work
Required skills
Quality assurance protocol design, Manufacturing compliance (GMP, ISO, GLP), Risk management, Validation, Six Sigma, Lean manufacturing, Total Quality Management, Internal auditing, Data analysis, Schematic and mechanical drawing review, Inspection tool configuration
Preferred skills
Medical device experience, Design team participation, CAPA management, Customer complaint processing, Document control, Nonconforming materials handling, Process controls, Receiving inspection, Training administration
Technologies
Microsoft Office, Excel, MiniTab
Responsibilities
Design and maintain QA protocols for processing materials into finished products; Plan and manage compliance of manufacturing processes with safety and regulatory standards; Analyze production data to identify trends and recommend updates to quality standards; Perform internal audits to ensure system compliance; Lead risk management, validation, and external standards review activities; Coordinate disposition of nonconforming materials; Review schematics and mechanical drawings; Apply inspection criteria using configured tools.
Seniority
Mid-level, hands-on IC