QA Design Transfer Engineer I/II - South Jordan, UT
Core
Ensures medical device products are designed, tested, and manufactured in compliance with quality requirements by supporting design transfer activities and process validation.
Role type
Quality Design Transfer Engineer
Builds
Medical devices and manufacturing processes
Domain
Medical device manufacturing / Quality Engineering
Deliverable
production ML models | product features | dashboards & analysis | research | client delivery | infrastructure | physical/clinical work
Required skills
21 CFR 820 knowledge, ISO 13485 knowledge, ISO14791 knowledge, statistical methodologies, root cause investigation, Six Sigma, project management, ECN generation, risk management analysis, nonconformance record review, containment procedures, quality system auditing
Preferred skills
Minitab, Oracle, ASQ Certified Quality Engineering, medical device industry experience
Technologies
Minitab, Oracle
Responsibilities
Guide design teams through Process Validation and Test Method Validation; coordinate process risk analysis and management activities; review and approve Engineering Change Notifications (ECNs); conduct technical studies for novel problems; evaluate work environment controls; review nonconformance records for root cause and corrective actions.
Seniority
Mid-level IC