Lead Design Control Engineer
Core
Manage quality systems, processes, and procedures to assure product safety, quality, and site compliance for the Haifa PoC Ultrasound business.
Role type
Senior Design Control Lead Quality Engineer
Builds
Total quality management system and compliance activities for the Ultrasound business
Domain
Medical Devices / Ultrasound
Required skills
Design controls, Design verification and validation, Design Transfer, Design changes, CAPA, complaints management, risk management, Root Cause Analysis, internal audits, regulatory requirements (FDA CFR 21 820, ISO 13485)
Preferred skills
Lean Certification, process implementation leadership, production and process controls
Technologies
MS Office (Word, Excel, PowerPoint, Database)
Responsibilities
Ensure compliance across Ultrasound business for Design Controls; Partner with Sourcing, Supplier Quality, and Service functions; Lead problem resolution and corrective actions for deviations, audits, and inspections; Drive Quality metrics and own the Quality Compliance Scorecard; Lead continuous improvement projects
Seniority
Senior, hands-on IC with leadership responsibilities