Easter Seals Jobs

[Abiomed] Quality Assurance Senior Specialist, QARA - 2406179759W

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

Qualifications

• 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

Primary Location Asia Pacific-Japan-Tokyo-To

Organization Abiomed Japan K.K. Legal Entity

Job Function Quality Assurance

Req ID: 2406179759W