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QA senior specialist

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Randstad

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Location:
Japan , Tokyo

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Category:
IT - Administration

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Contract Type:
Not provided

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Salary:

6000000.00 - 10000000.00 JPY / Year
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Job Description:

Lead quality initiatives and build a thriving QA function within a dynamic international team – a fantastic opportunity for experienced QA professionals! Our client is a leading global player in the biotech industry, renowned for its commitment to innovation and high-quality products. They are dedicated to providing cutting-edge solutions in the molecular diagnostics field, fostering a collaborative and supportive work environment.

Job Responsibility:

  • Lead quality initiatives and build a thriving QA function within a dynamic international team
  • Lead local project implementations and contribute to larger global projects
  • Maintain and improve the company's QMS, implementing local solutions as needed
  • Manage quality systems such as document control, utilizing global eQMS and eDMS/eTMS systems
  • Support internal, external (regulatory/Notified Body), and supplier audits
  • Collaborate with the Global CAPA team to resolve customer issues related to molecular diagnostic (MDx) products
  • Partner with the Warehouse/3PL team to ensure efficient operations, including product release and re-labeling
  • Handle quality-related inquiries

Requirements:

  • 3+ years of experience in Quality Assurance within a regulated IVD/MD company
  • Experience working in an international organization
  • Experience supporting audits with Competent Authorities/Notified Bodies
  • Excellent written and spoken English
  • Strong understanding of Japanese regulations for Molecular Diagnostics (IVDs) and Devices
  • Proven ability to lead projects and drive continuous improvement initiatives
  • Experience with eQMS and eDMS/eTMS systems
  • Strong collaboration and communication skills
  • Problem-solving and analytical skills
  • Experience working with 3PLs or warehouse management is a plus

Nice to have:

Experience working with 3PLs or warehouse management

What we offer:
  • 健康保険
  • 厚生年金保険
  • 雇用保険
  • 土曜日
  • 日曜日
  • 祝日

Additional Information:

Job Posted:
May 31, 2025

Expiration:
May 13, 2026

Employment Type:
Fulltime
Work Type:
Hybrid work
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