募集要項
- 募集背景
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Position: Senior Quality Assurance Specialist
As a Senior Quality Assurance Specialist, you will oversee quality assurance tasks related to medical devices, in vitro diagnostics, veterinary medicines, and research reagents, including consumables and equipment. You will collaborate with other quality assurance personnel to operate and maintain the Quality Management System (QMS), ensuring compliance with industry standards and regulatory requirements. Your role will involve implementing quality processes, conducting audits, and driving continuous improvement initiatives to maintain high-quality standards across all products and services.
- 仕事内容
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Responsibilities:
● Create and revise QMS documents.
● Develop and execute market launch plans with relevant departments.
● Create and revise legal labeling.
● Conduct risk analysis for product launches and modifications.
● Perform internal audits and evaluate suppliers.
● Manage domestic manufacturing contractors.
● Report defects to overseas sites, investigate causes, and implement corrective actions.
● Respond to QMS conformity assessments.
● Prepare documents for QMS conformity assessments required for manufacturing and marketing authorization.
- 応募資格
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- 必須
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Required Qualifications and Experience:
● Over three years of quality assurance experience in the medical device or in vitro diagnostics field.
● Experience with ISO 13485 conformity assessments by regulatory authorities or certification bodies.
● Business-level English proficiency for reading technical documents, handling emails, and participating in teleconferences.
Preferred Qualifications and Experience:
● Team leadership or management experience (people management experience not mandatory).
● Knowledge of research equipment and analytical reagents used by our company or competitors.
● Experience using ERP systems like SAP.
- 雇用形態
- Full-Time/正社員
- ポジション・役割
- Senior Quality Assurance Specialist
- 勤務地
- Tokyo
- 年収・給与
- 8 million yen ～ 9.99 million yen
