募集要項
- 募集背景
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This Senior Quality Assurance Specialist role is crucial for maintaining and improving the organization's Quality Management System (QMS) in compliance with ISO 9001 standards and medical device regulations. The position involves managing QMS operations, conducting employee training, liaising with certification bodies, and supporting departmental quality documentation.
Key responsibilities include performing internal audits, evaluating suppliers, handling defect reports, and preparing documentation for regulatory compliance. The specialist will also lead QMS-related initiatives, investigate quality issues, implement corrective actions, and ensure adherence to quality standards throughout the product lifecycle. This role requires expertise in quality assurance processes, strong communication skills, and the ability to navigate complex regulatory requirements in the medical device industry.
- 仕事内容
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Position: Senior Quality Assurance Specialist
Responsibilities:
As a member of the ISO Promotion Committee, manage the operation of the Quality Management System (QMS)
● Promote QMS activities in line with ISO 9001 standards
● Conduct internal training on QMS for all employees
● Coordinate and communicate with external/third-party certification bodies
● Support documentation of quality management systems in each department
● Plan and conduct periodic internal audits and management reviews
Implement measures to comply with ministerial ordinances for medical devices
● Create and revise QMS-related documents
● Conduct internal audits and supplier evaluations
● Report defects to overseas manufacturers, investigate causes through collaboration, implement corrective and preventive actions, and report to customers
● Prepare QMS conformity investigation documents for product manufacturing and sales approval/certification applications
● Respond to QMS conformity investigations
- 応募資格
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- 必須
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Required Qualifications and Experience:
● Educational background or experience meeting the requirements for a General Marketing Authorization Holder of Class III Medical Devices (see note)
● At least 5 years of quality assurance experience in medical devices or in vitro diagnostic medical devices
● Experience in responding to QMS conformity investigations by regulatory authorities or certification bodies, or ISO 13485 conformity investigations
● Business-level English proficiency (reading technical documents, handling emails and conference calls)
- 歓迎
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Preferred Qualifications and Experience:
● Team leader or team management experience (people management experience not required)
● Knowledge of the company's research equipment and analytical reagents, or experience with similar products from other companies (operation, repair, etc.)
● Experience using various ERP systems such as SAP
- 雇用形態
- Full-Time/正社員
- ポジション・役割
- Senior Quality Assurance Supervisor
- 勤務地
- Tokyo
- 年収・給与
- 8 million yen ～ 12.99 million yen
