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Quality

[Abiomed] Quality Assurance Senior Specialist, QARA

  • Titel [Abiomed] Quality Assurance Senior Specialist, QARA
  • Functie Quality
  • Sub functie Quality Assurance
  • Categorie Supervisor, Quality Assurance (PL5)
  • Locatie Tokyo-To, Japan
  • Gepost
  • Referentie 2406179759W
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Beschrijving

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

Kwalificaties

 <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

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