[Quality/ Medtech] Manager, Quality Assurance,Ethicon - 2406161690W

　　Description

　　SCOPE OF THE ROLE AND BASIC PURPOSE

　　Responsible for overall quality and compliance action such as complaint handling, field action, change control and so on in Japan market for Ethicon WC/Bio products.

　　Supervise JJKK QA Ethicon WC/Bio team to be compliant with Japanese regulations (primarily PMD Act and QMS Ordinance) and J&J Quality Policies cooperating with Quality Responsible Manager (Unseki).

　　Responsible for talent development for key staff to be grown.

　　Take a role of Quality Responsible Manager (Hinseki) for Drug. (Optional; if qualified)

　　KEY RESPONSIBILITIES/TASKS (indicate estimated % of time spent where possible)

　　1.50% - Team Management including supervision of all internal QA Ethicon WC/Bio related actions and people management

　　2.40% - Supervising complicated projects as Manager.

　　3.10% - Talent Development

　　ACCOUNTABILITIES/KEY MEASURES

　　Complaint Management (including cycle time management)

　　Field Action-Stop Shipment Management

　　Change Control including NPI

　　POSITION MANAGEMENT DIMENSIONS

　　Number of Employees to Supervise: 4

　　Limited Supervision: Determines own methods to accomplish work. Able to respond

　　independently to majority of complex problems on own

　　Qualifications

　　PERSON SPECIFICATION

　　Qualifications

　　Education & Training:

　　Must Have/

　　University Degree

　　Training (Quality, Regulatory)

　　Excellent English Writer

　　Nice to Have/

　　Post Graduate Technical Degree

　　Engineering

　　QMS Auditor

　　Excellent English Writer

　　Fluent Oral English

　　Six Sigma

　　Type of Professional Experience

　　 Quality Systems, Quality Control, Regulatory

　　at least 4 years

　　Nice to have

　　4years

　　Required Competencies and Skills

　　Excellent Communication skill in Japanese (interaction with auditors, government officials and internal stakeholders)

　　Logical Thinking/Decision Making

　　Good English Communication

　　Primary Location Asia Pacific-Japan-Tokyo-To-Chiyoda

　　Organization Johnson & Johnson K.K. (8235)

　　Job Function Customer/Commercial Quality

　　Req ID: 2406161690W