(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

• 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