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About the Role
This position supports the operation of the Quality Management System (QMS) in accordance with the Pharmaceutical and Medical Device Act (Yakki-hou) and ISO 13485. You will be responsible for creating and maintaining QMS-related documents, system operations, quality data aggregation and analysis, and supporting processes such as training and CAPA. You will collaborate with internal stakeholders to contribute to maintaining and improving the quality of medical devices and the continuous improvement of the QMS.
Responsibilities
- Operation and support of Quality Management System (QMS) related tasks based on the Pharmaceutical and Medical Device Act and ISO 13485.
- Creation, revision, and maintenance of QMS-related documents such as product standards and package inserts.
- Operation and management of QMS-related systems (account management, system settings, workflow/inquiry response, etc.).
- Aggregation, analysis, and reporting of QMS-related data.
- Operational support for QMS processes such as training and CAPA.
- Other tasks related to the operation of the Quality System Group.
Requirements
- Basic PC skills (Word, Excel [basic functions, VLOOKUP, etc.], PowerPoint, Outlook, etc.).
- Ability to work smoothly with internal stakeholders through effective communication.
Skills
- Medical device, pharmaceutical manufacturer work experience
- Basic knowledge or work experience in Pharmaceutical and Medical Device Act, ISO 13485, QMS
- Work experience in quality assurance, document control, QMS systems, etc.
- Experience in data aggregation, analysis, and reporting
- Comfortable reading and writing emails and documents in English
Location
- Tokyo, Japan
Work Type
- Full-time
- Hybrid
Experience Level
- Entry Level
- Mid Level
Salary/Compensations
- 3,500,000 JPY - 4,200,000 JPY
Benefits
- Annual salary increase
- Annual bonus (performance-based)
- Commuting allowance (company regulations apply)
- Retirement plan
- Employee savings plan
- Welfare program (Benefit Station)
- Health support: Full subsidy for influenza vaccination and health check-up costs
- One company-designated holiday
- Social insurance (Employment, Workers' Compensation, Health, Welfare Pension)
- No smoking indoors
About the Company
- Medline Japan LLC is the Japanese subsidiary of Medline Inc. We manufacture and sell medical devices and supplies for medical institutions, including surgical preparation kits, non-woven products such as gowns and drapes, operating room related products, surgical and examination gloves, personal protective equipment, respiratory therapy products, and vascular catheter related products.
- In Japan, we have our Tokyo headquarters, branches and sales offices in major cities, as well as a surgical preparation kit factory, distribution center, and sterilization center.
- For more details, please visit our website: https://www.medline.co.jp