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J&J Family of Companies [Quality/ Medtech] Manager, Quality Assurance,DePuy Synthes in Tokyo, Japan

[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)

  1. 50% - Team Management including supervision of all internal QA DePuy Synthes JDBS related actions and people

management.

  1. 40% - Supervising complicated projects as Manager.

  2. 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

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