Quality Engineer
Core
Lead Quality Management System (QMS) activities to ensure medical device design and manufacturing at the Hino factory comply with global regulations (FDA, MDR) and internal standards, facilitating audits and inspections.
Role type
Senior Quality Engineer (Medical Devices)
Builds
Compliant medical device designs and manufacturing processes for global customers
Domain
Medical Technology / Regulatory Compliance
Deliverable
production ML models | product features | dashboards & analysis | research | client delivery | infrastructure | physical/clinical work
Required skills
Quality Management System leadership, Design Control expertise, Production & Process Control knowledge, Regulatory audit facilitation, Cross-functional collaboration
Preferred skills
None stated
Technologies
None stated
Responsibilities
Guide design and manufacturing activities to meet regulatory and QMS requirements; Facilitate reviews and discussions with global members on product development and production transfer; Lead and facilitate corrective and preventive actions for non-conformities; Respond to external audits by regulatory authorities and certification bodies; Develop and execute internal audit plans.
Seniority
Senior, hands-on IC
