Senior QA Design Transfer Engineer I - South Jordan, UT
Core
Senior Quality Engineer ensuring design transfer from R&D to manufacturing for medical devices, managing design controls, risk analysis, and quality system compliance.
Role type
Senior IC Quality Engineer (Medical Devices)
Builds
Medical devices (catheters, surgical instruments, etc.)
Domain
Medical Devices / Regulatory Compliance
Required skills
Design Control, Risk Management, Root Cause Analysis, Process Validation, Test Method Validation, 21 CFR 820, ISO 13485, Six Sigma, Lean Manufacturing, Engineering Change Management, Quality Auditing
Preferred skills
Minitab, JMP, Oracle, ASQ Certified Quality Engineer, Medical Device Industry Experience
Technologies
Minitab, JMP, Oracle
Responsibilities
Guide design team on Design Control from Inputs through Outputs and Device Master Record creation; Lead risk management analysis and mitigation; Review and approve Engineering Change Notifications (ECNs); Conduct technical studies for novel problems; Mentor engineers and Quality Auditors; Review nonconformance records and drive corrective actions; Support internal and supplier audits.
Seniority
Senior, hands-on IC with mentorship