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**Job Function: **
Quality
**Job Sub Function: **
Customer/Commercial Quality
Job Category:
Professional
All Job Posting Locations:
Chiyoda, Tokyo, Japan
Job Description:
SCOPE OF THE ROLE AND BASIC PURPOSE
▪ Responsible for establishing methods of quality assurance, providing these methods to relevant departments, and maintaining them so that intended products are consistently delivered to customers.
▪ Responds to information on product defects and customer complaints, contributing to both productivity and customer satisfaction, as well as to product quality improvement.
**KEY RESPONSIBILITIES/TASKS **
Supplier Management
▪ Guide and supervise overseas manufacturing sites to ensure they meet Japanese legal requirements (e.g., site certification or registration activities, QMS compliance of overseas facilities).
▪ Manage and guide other companies involved in J&J marketed products.
▪ Monitor, manage, and provide improvement guidance for deliverables from suppliers involved in QA-managed processes.
**General QMS **
▪ Ensure competency and provide training to internal and external stakeholders involved in QA-managed processes.
**New Product Introduction (Design Control) **
▪ Understand design control, mass-production transfer, and manufacturing/quality control processes, and establish methods for ensuring product quality throughout each process.
▪ Confirm compliance when new or revised technical standards applicable to products are issued.
**Order Receipt & Shipment **
▪ Build systems related to product shipment to the market, approve shipment acceptance or rejection in the event of deviations or non-conformities, and issue instructions for shipment holds/releases.
Manufacturing and Service
▪ Manage the execution status of quality operations in domestic final storage.
▪ Guide and supervise overseas manufacturing sites to ensure they meet Japanese legal requirements (e.g., site certification or registration activities, QMS compliance of overseas facilities).
**Repair, Installation, and Ancillary Services **
- Review & Approve documents related to product quality (documents: specifications, procedures, rules, records).
**Customer Complaint Management **
▪ Manage customer feedback (including complaints) processes and perform complaint-handling operations.
**Product Inspection & Product Improvement **
▪ Review & Approve documents related to product quality (documents: specifications, procedures, rules, records).
▪ Promote corrective and preventive actions related to product quality issues and provide input to the Franchise for product improvement.
**System Improvement Management / CAPA **
▪ Manage recall processes and carry out recall activities (regulatory communication, progress management, confirmation of recalled items).
▪ Act as an SME (Subject Matter Expert) during audits in the capacity of product Quality representative)
**ACCOUNTABILITIES/KEY MEASURES **
▪ Complaints Management- On time analysis and customer feedback
▪ QMS & FMR- Timely completion for both of NPI & LCM projects
▪ Quality Actions such as Stop Shipment, Field Actions- Timely actions/completion
**Required Competencies and Skills **
▪ Excellent Communication skill in Japanese (interaction with auditors, government officials and internal stakeholders)
▪ Logical Thinking/Decision Making
▪ Good English Communication
**Required Skills: **
Preferred Skills:
Business Behavior, Compliance Management, Continuous Improvement, Data Analysis, Data Compilation, Detail-Oriented, Execution Focus, Goal Attainment, Internal Controls, Issue Escalation, Process Oriented, Quality Control (QC), Quality Management Systems (QMS), Quality Standards, Regulatory Environment, Report Writing