Manufacturing Quality Assurance Engineer III
Core
Provides complex quality engineering work for specific medical device product lines, focusing on failure investigation, risk analysis, supplier quality, and validation protocols.
Role type
Manufacturing Quality Assurance Engineer
Builds
Medical devices
Domain
Medical Devices / Manufacturing
Deliverable
production ML models | product features | dashboards & analysis | research | client delivery | infrastructure | physical/clinical work
Required skills
Failure investigation, Risk analysis (FMEA), Supplier quality audits, Validation protocol generation, Nonconformance disposition, Quality system optimization, Statistical methodologies, Lean manufacturing, Six Sigma, 21 CFR 820 compliance, ISO 13485 compliance
Preferred skills
SmartCAPA, Oracle, Crystal Reports, Deviation handling, CAPA management
Technologies
Oracle, Crystal Reports
Responsibilities
Investigate failures and determine disposition of nonconforming materials, Conduct and update risk analysis documentation, Define and refine quality inspection plans, Monitor supplier performance and conduct audits, Review and generate Engineering Change Notifications (ECNs), Ensure containment of nonconforming product
Seniority
Mid-level IC