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Updated 2025-01-16
Activated 2025-01-16
Activated 2025-01-16
Device Quality Assurance, Manager/Senior Manager
| This posting is managed by: | Cornerstone Recruitment Japan K.K. |
|---|---|
| Company Name | Company is not publicly visible |
| Job Type |
 Medical/Pharmaceutical/Bio/Fabric/Food - QA/QC |
| Location |
Asia
Japan
Tokyo
|
| Job Description | Develop, review, and maintain documentation for the company’s device quality management system processes.Assess and manage suppliers both domestically (in Japan) and internationally, collaborating to resolve quality issues.Lead or support internal and external audits, offering expertise as needed.Collaborate with a global, multidisciplinary team to oversee activities such as feedback and complaint handling, nonconformance management, corrective and preventive actions (CAPA), change control, and supplier evaluations.Stay updated on current regulations, standards, and guidance related to quality management systems and medical devices. |
| Company Info | Japanese lobal biotechnology company dedicated to developing precision, cell-targeting therapies based on its technology platform |
| Job Requirements |
Education: A university degree.Experience: Minimum of 3 years in the medical device industry, with candidates having more experience considered for senior roles. Quality Assurance Expertise: Experience in the following areas: Quality management systems (e.g., ISO 13485).CAPA, nonconformance management, and handling feedback and complaints. Internal and external audits, including regulatory inspections by authorities, notified bodies, or customers . Regulatory Knowledge:Familiarity with Japan’s PMD Act, relevant regulations, and guidelines. Strong understanding of ISO 13485 and MHLW MO 169 is essential. Knowledge of FDA 21 CFR Part 820 is an advantage. Familiarity with risk-based approaches like ISO 14971 is a bonus. Language Skills:Proficiency in Japanese (verbal and written).Strong preference for candidates fluent in English for communication with global business partners. Communication: Excellent verbal and written communication skills. |
| English Level | Business Conversation Level (TOEIC 735-860) |
| Japanese Level | Native Level |
| Salary | Depends on experience |
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