Quality Engineer P2
Core
Lead and execute quality activities for a strategic manufacturing site transfer of sterile medical devices, ensuring compliance with global regulatory requirements and patient safety standards.
Role type
Quality Engineer II (Manufacturing Site Transfer)
Builds
Galil Medical Cryoablation Needles (sterile, single-use medical devices for cancerous tissue treatment)
Domain
Medical Devices / Cryoablation / Manufacturing Quality
Deliverable
production ML models | product features | dashboards & analysis | research | client delivery | infrastructure | physical/clinical work
Required skills
Quality system compliance, manufacturing site transfer management, process validation (MVP/R, OQ, PQ), supplier and material qualification, regulatory submissions, cleanroom establishment, MES implementation, risk assessment, knowledge transfer coordination
Preferred skills
Experience with Guardian system, Design Assurance partnership, equipment qualification, environmental monitoring, microbiological control
Technologies
Manufacturing Execution System (MES), Guardian system
Responsibilities
Own the Manufacturing Site Transfer Quality Plan, lead quality activities for site transfer, coordinate documentation transfer, support cleanroom and manufacturing line qualification, lead process validation activities, lead supplier and material qualification, partner on test method transfers, implement MES activities, coordinate knowledge transfer, support production control implementation, establish environmental monitoring, support finished goods acceptance, partner on decommissioning, mitigate quality risks, ensure project milestones
Seniority
Mid-level, hands-on IC
