Job Information
J&J Family of Companies [MedTech] Manager, Quality Assurance, DePuy Synthes in Tokyo, Japan
[MedTech] Manager, Quality Assurance, DePuy Synthes - 2406192519W
Description
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/.
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 people
management.
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: 2406192519W