The successful candidate will be responsible for:

• Supporting the QA Senior Manager in the following activities:

+ Market Release and Distribution Control including management of non-conformity + Oversight of Final release, Quality Control and Manufacturing Control, including establishment /update of quality criteria in Japan 3PL manufacturers + Translating English Complaint investigation report and preparing Customer letter in Japanese (including correspondence with overseas manufacturers)

• Creating QMS documents, records, and reports, including English-to-Japanese translation and Japanese-to-English translation
• Managing change control, SOPs, and records
• Establishing and updating product standards, quality agreements, and licenses
• Managing corrective action and preventive action
• Providing training to dedicated employees
• Handling recalls and license applications
• Supporting onsite audits

The ideal candidate will have:

• Bachelor's degree or graduation from a technical college
• Minimum two years of professional experience in a related field (Quality, Manufacturing, Regulatory department in Medical device or Electrical product field)
• Fluent Japanese and English skills (TOEIC 700+)
• PC skills (Word, Excel, PowerPoint)
• Ability to work in a remote environment (3-4 days per week)

If your interests and skills are a good match, you may have the opportunity to undertake QMS-related consulting work.

IQVIA is an equal opportunity employer and values diversity.

Job Data by YubHub.