Description
At Johnson & Johnson, we believe health is everything. Our strength in healthcare innovation empowers us to build a world where complex diseases are prevented, treated, and cured, where treatments are smarter and less invasive, and solutions are personal. Through our expertise in Innovative Medicine and MedTech, we are uniquely positioned to innovate across the full spectrum of healthcare solutions today to deliver the breakthroughs of tomorrow, and profoundly impact health for humanity. Learn more at jnj.com.
As guided by Our Credo, Johnson & Johnson is responsible to our employees who work with us throughout the world. We provide an inclusive work environment where each person is considered as an individual. At Johnson & Johnson, we respect the diversity and dignity of our employees and recognize their merit.
Job Function:
QualityJob Sub Function:
Customer/Commercial QualityJob Category:
ProfessionalAll Job Posting Locations:
Chiyoda, Tokyo, JapanJob 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
1. 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