Job Description & How to Apply Below
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 (e.g. new product introduction).
Represent the company against all applicable Japanese regulatory bodies as required under Quality Assurance related to Japanese regulation.
CORE JOB RESPONSIBILITIES
– list the primary tasks or activities this job performs on an ongoing basis.
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 (e.g. 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 )
– define the size of the organization this job is responsible for as well as the level of the positions reporting into this job.
Quality Assurance Group
MINIMUM SKILLS REQUIRED
– identify the specific skills needed to perform this job effectively (leadership skills, selling skills, computer literacy, etc.)
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
– describe the on the job experience level required to perform this job (e.g. 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.
Less than 1 Year
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