Senior Specialist Quality Assurance
Core
Ensure all activities comply with quality system requirements and support business operations in Japan for the Vascular division.
Role type
Senior Specialist Quality Assurance (Medical Devices)
Builds
Quality Management System procedures and compliance for Vascular products
Domain
Medical Devices / Vascular / Regulatory Compliance (Japan)
Required skills
Quality Management System (QMS), PMD Act, Change Management, Document Control, Product Approval, Production Controls, Corrective and Preventive Action, Post Market Support
Preferred skills
ISO13485 Lead Auditor, Vascular product clinical usage, Medical device logistics and supply chain, Medical device consignment sales business style
Technologies
Word, Excel, PowerPoint
Responsibilities
Ensure activities comply with quality system requirements; Support developing and maintaining necessary procedures in compliance with PMD Act and corporate policies; Participate in developing the Quality Assurance organization and monitor compliance; Provide recommendations to Line manager regarding safety and quality measurements; Implement or manage main quality processes including sub-processes; Support implementation of impact goals for other departments of QSC; Participate in OACA-related activities and support implementation of OACA processes in Japan.
Seniority
Senior, hands-on IC