• AVJSenior Manager QA, Safety Jobs in Japan

  • Abbott India Ltd
  • Japan

Job Description:

JOB PURPOSE AND SCOPE

describe in 3-4 short sentences the responsibility and authority (budget, revenue, internal/external contacts, etc) of the job

Develop and maintain the organization in the quality standard exceeding customer expectations and coordinates activities with internal and external customers
As Quality Officer of MAH, responsible for adherence to Abbott Vascular Japan quality management system (QMS) per related Pharmaceutical, Medical device, etc Law (Japanese regulation) and AV and Abbott Corporate policies and relevant company procedures
Manage department activities for supporting business in Japan (eg new product introduction)
Represent the company against all applicable Japanese regulatory bodies as required under Quality Assurance related to Japanese regulation

CORE JOB RESPONSIBILITIES

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Develop and maintain the necessary procedures in compliance with Japanese regulation and AV and Abbott Corporate policies to perform Quality Assurance activities
Develop Quality Assurance organization, demonstrate effective leadership of Quality Assurance activities and monitor compliance with Japanese regulation and relevant company procedures
Develop and support implementation of impact goals and growth plan for the department members
Provide recommendations to upper management and MAH Officer regarding safety and/or quality measurement (eg product removal due to significant patient injury by product malfunction)
Provide information of significant product quality issue and results of monitoring Quality Assurance activities to upper management, MAH Officer, GVP Officer and Business Units
Manage the responsible operational budget effectively
Plan and drive to work towards achieving company vision, objectives as well as divisional mission and strategies
Motivate and develop staff
May assign ad hoc project as required

SUPERVISORY/MANAGEMENT RESPONSIBILITIES (if applicable)

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Quality Assurance Group

MINIMUM SKILLS REQUIRED

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Leadership skills
Basic level English conversation, presentation, reading and writing skills to be able to communicate with business partners

KNOWLEDGE / EDUCATION REQUIRED

identify the knowledge, expertise, educational level required to perform this job successfully (product /industry knowledge, technical /business acumen, university degree, professional certification, etc)

4 year university degree of medical, pharmacology, scientific or engineering related fields, preferred
Knowledge of QMS and GVP regulations
Basic knowledge of clinical usage for Vascular products, product design and manufacturing process

EXPERIENCE REQUIRED

describe the on the job experience level required to perform this job (eg years of management experience, years of experience in a certain discipline, etc)

Over 3 years experience in Quality Assurance or equivalent
Over 3 years experience in safety, quality or technical area in medical device industry, preferred
Over 3 years experience in people management of over 5 staffs or equivalent

Profile Summary:

Employment Type : Full Time
Eligibility : Any Graduate
Industry : Healthcare, Manufacturing/Industrial
Functional Area : Production/Manufacturing/Maintenance/Packaging
Role : Production/Manufacturi ng/Maintenance
Salary : As per Industry Standards
Deadline : 08th Apr 2020

Key Skills:

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