[Abiomed] Quality Assurance Senior Specialist, QARA
Posted:
Friday, 12 April 2024
Valid Thru:
Sunday, 12 May 2024
Index Requested on:
04/12/2024 14:00:09
Indexed on:
04/12/2024 14:00:09
Location:
To, 13, , JP
Industry:
Advertising and Public Relations
Occupational Category:
13-0000.00 - Business and Financial Operations
Type of Employment: FULL_TIME
Johnson and Johnson is hiring!
Description:
Job Responsibilities: Sr. QA Specialist is responsible for all duties in Quality Department. Sr. QA Specialist reports to Sr. QA Manager.
Principle Duties and Responsibilities :
Sr. QA Specialist supports Quality Assurance related activities shown below:
- Handling customer impacting issues and prioritizing quality and compliance minded solutions.
- Creating and maintaining Device Master Record (DMR)
- Controlling product change management
- Collaborating with global and third-party manufacturing team
- Conducting incoming inspection, product release, and storage related activities
- Facilitating and leading field action activities in Japan
- Controlling QMS compliance inspection activities
- Maintaining and updating marketing authorization licenses, other licenses, and registration and renewal of foreign medical device manufactures
- Experience for working more than three years in Quality Assurance in medical device companies or equivalent
- Basic knowledge in Pharmaceutical and Medical Device Act (PMD Act) and QMS Ordinance
- Fluency in Japanese and English writing and communication skills
- Basic personal computer skills (Microsoft Word, Excel, PowerPoint and Access)
- Experience in working in cardiac related medical device companies
- Knowledge in cardiac related medical device products
- Business level English writing and communication skills
*Work Location - 2-chome Nihonbashi Muromachi, Chuo-ku, Tokyo
Responsibilities:
Please review the job description.
Educational requirements:
Desired Skills:
Please see the job description for required or recommended skills.
Benefits:
Please see the job description for benefits.
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