# QMS Support Specialist

**Company**: IQVIA
**Location**: Shinjuku, Tokyo
**Work arrangement**: hybrid
**Experience**: mid
**Job type**: full-time
**Category**: Healthcare
**Industry**: Healthcare

**Apply**: https://iqvia.wd1.myworkdayjobs.com/en-US/IQVIA/job/Shinjuku-Tokyo-Japan/Associate--Quality-Assurance_R1545758-1?utm_source=yubhub.co&utm_medium=jobs_feed&utm_campaign=apply
**Canonical**: https://yubhub.co/jobs/job_91f2ab9b-3fe

## 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.

## Skills

### Required
- Japanese
- English
- Quality Management
- Regulatory Compliance
- Medical Devices
- Electrical Products
- Word
- Excel
- PowerPoint

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Source: [Apply at iqvia.wd1.myworkdayjobs.com](https://iqvia.wd1.myworkdayjobs.com/en-US/IQVIA/job/Shinjuku-Tokyo-Japan/Associate--Quality-Assurance_R1545758-1?utm_source=yubhub.co&utm_medium=jobs_feed&utm_campaign=apply)