[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:

  • high school

Desired Skills:

Please see the job description for required or recommended skills.

Benefits:

Please see the job description for benefits.

Apply Now