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About the Role
This role involves supporting the QA Senior Manager in operating and maintaining a proper Quality Management System, understanding requirements from QMS/PMD Act, and potentially undertaking QMS-related consulting work.
Responsibilities
- Support the department head's activities.
- Establish/update quality criteria in Japan 3PL manufacturers, including management of non-conformity.
- Manage market release and distribution control.
- Translate English complaint investigation reports and prepare Japanese customer complaint reports, including correspondence with overseas manufacturers.
- Prepare and file other QMS documents and records, including English-to-Japanese and Japanese-to-English translations.
- Handle email and telephone correspondence in both Japanese and English.
- Manage change control.
- Control SOPs and records.
- Establish and update product standards.
- Establish and update quality agreements with license holders and domestic manufacturers.
- Manage corrective and preventive actions.
- Manage purchasing, including oversight of license holders.
- Manage employee training.
- Handle recalls.
- Handle applications for MAH license approval and distributor license.
- Support onsite audits from regulatory bodies like PMDA and notified bodies, as well as customer audits.
- Create applications for QMS inspection and FMR documents, including explanations of QMS/FMR to clients (license holders).
Requirements
- Bachelor’s degree or graduation from a technical college.
- Minimum of two years of professional experience in Quality, Manufacturing, or Regulatory departments within the Medical device or Electrical product field.
- Business-level English speaking skills.
- TOEIC score of 700 or higher (for reading, writing, and email communication).
- Proficiency in PC skills including Word, Excel, and PowerPoint.
- Ability to translate simple sentences between Japanese and English without a dictionary or tool.
- Ability to communicate smoothly with internal and external customers.
- Occasional travel is required, including visiting overseas manufacturers for training.
Skills
- Quality Management System (QMS)
- Regulatory Affairs
- Document control
- Change control
- Corrective and Preventive Action (CAPA)
- Auditing
- Translation (Japanese/English)
- PC Skills (Word, Excel, PowerPoint)
Location
- Remote (3-4 days per week)
Work Type
- Remote
- Hybrid
Experience Level
- Minimum two years of professional experience
Education Level
- Bachelor's degree
- Graduation from a technical college
About the Company
- IQVIA is a leading global provider of clinical research services, commercial insights, and healthcare intelligence to the life sciences and healthcare industries.
- We create intelligent connections to accelerate the development and commercialization of innovative medical treatments to help improve patient outcomes and population health worldwide.
- IQVIA is committed to integrity in our hiring process and maintains a zero tolerance policy for candidate fraud.
Equal Opportunity
- We are an equal opportunity employer and value diversity.
- All employment is decided on the basis of qualifications, merit and business need.
- We are an equal opportunity employer and value diversity. All employment is decided on the basis of qualifications, merit and business need.