[Quality/ Medtech] Manager, Quality Assurance,DePuy Synthes - 2406161953W

　　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 DePuy Synthes Joint Digital Biomaterial and Spine (JDBS) products.

　　 Supervise JJKK QA DePuy Synthes JDBS 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.

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

　　50% - Team Management including supervision of all internal QA DePuy Synthes JDBS related actions and peoplemanagement.

　　40% - Supervising complicated projects as Manager.

　　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: 5

　　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: 2406161953W