Quality Engineer
Core
Develop and maintain systems, rules, and processes to ensure fulfillment of internal and external requirements for medical devices designed and manufactured at the Hino factory, ensuring compliance with global regulations and GEHC's Quality Management System.
Role type
Quality Management System Lead / Quality Engineer
Builds
Medical device design and manufacturing activities compliant with FDA, MDR, and internal QMS
Domain
Medical Technology / Regulatory Compliance
Required skills
Quality Management System leadership, Design Control understanding, Production & Process Control knowledge, Global cross-functional communication, Audit and inspection management, Non-conformance handling
Preferred skills
None stated
Technologies
None stated
Responsibilities
Guide design and manufacturing activities at Hino factory per global regulations and QMS; Facilitate reviews and discussions with global members on product development and production transfer; Respond to external audits and inspections by regulatory authorities; Lead and facilitate corrective and preventive actions for non-conformances; Develop and implement internal audit plans.
Seniority
Senior, hands-on IC