Quality Management System Administrator (New Health Care Company)

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Job Description:

Quality Management System Administrator (New Health Care Company)

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

Must be legally authorized to work in country of employment without sponsorship for employment visa status (e.g., H1B status).

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