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| 部署・役職名 | Quality Assurance Associate Manager |
|---|---|
| 職種 | |
| 業種 | |
| 勤務地 | |
| 仕事内容 |
With a comprehensive understanding of quality assurance processes for medical devices and the Pharmaceuticals and Medical Devices Act, you will ensure smooth execution of your duties while collaborating with team members to drive continuous improvements within the organization. Your responsibilities will include managing quality assurance functions and maintaining compliance with regulatory standards for products manufactured and sold by the company. Responsibilities: ◇ Ensure operations comply with the Pharmaceuticals and Medical Devices Act and the QMS Ministerial Ordinance. ◇ Manage reception, processing of quality information, and provide customer support. ◇ Maintain compliance with ISO standards. ◇ Encourage foreign manufacturers to maintain and improve product quality. ◇ Lead and coordinate product recall or repair efforts, including communication with authorities. ◇ Oversee pharmaceutical affairs, public relations (PMDA, Tokyo Metropolitan Government), and manage foreign manufacturer registrations and QMS inspections. |
| 応募資格 |
【必須(MUST)】 ◇ Strong knowledge of the Pharmaceutical and Medical Device Act.◇ 3+ years of experience in quality assurance for medical devices. ◇ Practical experience in manufacturing management and quality assurance is a plus. ◇ Proven experience leading teams or projects. ◇ Science background preferred, with the ability to understand product mechanisms and communicate effectively with logical thinkers. ◇ Proficient in English communication (verbal and email) and capable of smooth collaboration across departments and with external stakeholders. |
| リモートワーク | 可 「可」と表示されている場合でも、「在宅に限る」「一定期間のみ」など、条件は求人によって異なります |
| 受動喫煙対策 | 喫煙室設置 |
| 更新日 | 2025/01/30 |
| 求人番号 | 4299118 |
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- 会社規模501-5000人
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- Life Sciences, Morgan McKinley Specialised in Commercial Leadership (Sales, Marketing, ComEx) for medical device clients.
- (2025/08/04)
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