Quality Engineer lll
Core
Ensuring compliance with quality system requirements and supporting process/product validation for structural heart disease device solutions.
Role type
Quality Engineer III (Manufacturing/Regulatory)
Builds
Device and management solutions for structural heart disease treatment
Domain
Medical Devices / Structural Heart
Deliverable
client delivery
Required skills
Root Cause Analysis, Six Sigma, Statistical analysis, FDA/GMP/ISO 13485 compliance, Process validation, Nonconforming material control, CAPA management, IQ/OQ/PQ/PPQ execution
Preferred skills
SAP, ASQ CQE certification, Multi-department project leadership, Supervision experience
Technologies
MS Excel, MS Word, MS PowerPoint, SAP
Responsibilities
Conduct technical and statistical investigations for optimization and compliance; Support/own Major Quality System investigations (CAPAs, HHEs, StopShip); Execute and author product qualification protocols (IQ, OQ, PQ, PPQ); Support internal and external audits; Perform supervisor activities for Quality Technicians.
Seniority
Mid-level, hands-on IC with potential supervision