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(Quality/ Medtech) Manager, Quality Assurance,Ethicon
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 ownPERSON 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
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 ownPERSON 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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