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Quality Assurance Specialist

  • Tokyo, TOKYO, Japan
  • Not Remote
  • Quality & Regulatory
  • JOB7311

Company Description







Job Description

Primary Function of Position:

  • Manage and implement required actions to maintain existing product lines and to solve any product quality issues occurred in Japanese market.
  • Take timely and appropriate quality management actions and executing communications with government and internal / external customers.

Roles and Responsibilities:

This position has mainly following responsibilities and authorities to timely deliver effective and safety products in Japanese market, to reduce customer complaint/malfunction, and to improve product quality:

  • Collaborate with QRC team to maintain Quality Management System.
  • Work related to product realization (control DMRs and materials for released products etc.)
  • Operate product release (IQC, labeling instructions, and market release assessment etc.)
  • Manage non-conforming products (rework, concession, and hold etc.)
  • Lead risk management team and implement risk management activities from the viewpoint of product and subcontractors / suppliers in cooperation with related functions.
  • Assess change notifications from headquarters and manufacturing sites, and implement necessary actions in cooperation with related functions.
  • Work related to data analysis and CAPA.


Skill/Job Requirements:

  • Minimum Education:
    • Bachelor or higher degree  (Preferred: Physics, Chemistry, Biology, Material Engineering, Electrical Engineering, Mechanical Engineering or Pharmacology)
  • Background:
    • Minimum 3 years experience in Pharmaceutical/Medical Device/IVD industries 
    • Minimum 3 years experience related to Quality in any manufacturing industries
  • Skill / Experience:
    • Must:
      • Good interpersonal/communication skill to work well with cross-functional teams
      • Analytical mindset and ability to see the big picture
      • Project management skill
      • Logical thinking skill
      • Strong willing to achieve goals
      • Verbal and written communication in English and Japanese
      • Knowledge of basic Quality Management System (e.g. ISO 9001) / Quality Assurance / Quality Control methodology
      • Basic PC skill (e.g. Microsoft Word /Excel / Powerpoint)
    • Preferred:
      • Knowledge of J-PMD Act, relevant regulations, ISO 13485 and ISO 14971
      • Experience of complaint handling and/or complaint product investigation
      • Experience of using Oracle Agile PLM, SAP, Trackwise, and/or HP ALM

Additional Information



Shift: Day
Travel: 10% of the time

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