Abiomed Quality Assurance Senior Specialist, QARA

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

<Requirements>

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)

<Preferences>

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

If you are Japan employee, please read “Internal Application Guideline” in Ask GS. Especially if you are less than 18 months in your current role, you are required to obtain application approval from your current manager as well as your respective BUHR. If you are Japan’s employee, you are not able to apply for multiple positions at once.

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