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Quality Management System Administrator

年収:800万 ~ 1100万

採用企業案件

特集求人

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スリーエムへルスケアジャパン合同会社

スリーエムへルスケアジャパン合同会社

  • 東京都

    • 会社規模非公開
  • 専門商社
部署・役職名 Quality Management System Administrator
職種
業種
勤務地
仕事内容 In the QMS Management Department of the Healthcare Business Group, the QMS member will be responsible for the operation of internal systems related to quality management in accordance with ISO 13485 and 9001, and for the maintenance and management of various business categories.

The Impact You’ll Make in this Role

As a QMS Administrator, you will be in charge of maintain and manage ISO13485 and 9001 certifications appropriately.

To build good relationships with related departments in Japan and overseas, improve processes, and strive to enhance the quality of quality control operations.

Operate and improve quality control processes in line with Global QMS and related domestic regulations.

Operate and improve quality control processes in accordance with ISO 13485 and ISO 9001 standards.

Maintenance of procedures and various archived documents related to quality control operations (records, revision work, etc.)

Application for and response to QMS conformity surveys

Maintenance and management of certificates of conformity to standards

Registration and maintenance of domestic and overseas manufacturing operations

Conducting internal and supplier audits

Response to inspections by government and certification bodies

Reporting and handling of recall reports and other administrative reports

Implementation of education and training related to quality management operations

Management of other QMS management operations

Your Skills and Expertise




To set you up for success in this role from day one, 3M requires (at a minimum) the following qualifications:

Experience and Qualifications

Required Requirements

Experience in quality control operations for medical devices or pharmaceuticals (5 years or more)
Expert knowledge of QMS, GQP, GMP and other related laws and regulations
English skills to negotiate with foreign countries. (TOEIC 600<)
Excellent communication and project management skills with other department staffs.
Preferred Requirements

ISO13485 auditor certification
Experience in implementing quality improvement projects
Qualified pharmacist
Work location: Tokyo, Japan

Work Your Way Eligible (Employee choice to work remote, on site, or hybrid)
Hybrid Eligible
応募資格

【必須(MUST)】

ISO 9001 certification
ISO13485 Certification
English Skill

【歓迎(WANT)】

ISO13485 auditor certification

受動喫煙対策

喫煙室設置

更新日 2024/02/29
求人番号 3336821

採用企業情報

スリーエムへルスケアジャパン合同会社
  • スリーエムへルスケアジャパン合同会社
  • 東京都

    • 会社規模非公開
  • 専門商社
  • 会社概要

    【代表者】宮崎 裕子
    【本社所在地】東京都品川区北品川6-7-29

    【事業内容】ヘルスケアに係る各種製品、複合製品及び関連製品の開発・製造・輸出入・加工・販売 等

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