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 Qualifications <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