Description
We are seeking a QMS Support Specialist to support the QA Senior Manager in driving forward proper Quality Management system operation and maintenance.
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.