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Quality

[MedTech] Manager, Quality Assurance, DePuy Synthes

  • 標題 [MedTech] Manager, Quality Assurance, DePuy Synthes
  • 功能 Quality
  • 子功能 Customer/Commercial Quality
  • 類別 Manager, Customer/Commercial Quality (P7)
  • 位置 Chiyoda, Tokyo-To, Japan
  • 刊登日期
  • 參考 2406192519W
馬上申請
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描述

**About Johnson & Johnson**

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 [https://www.jnj.com/.](https://www.jnj.com/)


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.
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: 5

Limited Supervision: Determines own methods to accomplish work. Able to respond 
independently to majority of complex problems on own 

資格

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

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