[Quality] Manager Quality Assurance [Shockwave]

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We provide an inclusive work environment where each person is considered as an individual.

At Johnson & Johnson, we respect the diversity and dignity of our employees and recognize their merit.

Job Function:
Quality

Job Sub Function:
Quality Assurance

Job Category:
Professional

All Job Posting Locations:
Chuo-ku, Tokyo, Japan

Job Description:

Essential Job Function


* Responsible for maintaining the Quality Management System (QMS) in compliance with MHLW ordinance No 169 (QMS ordinance) and other regulatory requirements.


* Ensure Quality Management System procedures are established and maintained in compliance to International, National and Local regulatory requirements and company's policies.


* Identify changes to relevant regulatory requirements and industry standards


* Undertake gap assessment activities to newer regulatory requirements


* Work cross functionally to address the identified system gaps and implement changes


* Train the organization to ensure the new requirements are communicated internally

Manage the NCR process


* Administer and manage the NCR process and maintain overall compliance to relevant procedures


* Collect and analyze data from various processes (NCRs) for periodic reviews


* Coordinate with cross functional team members to collect relevant data and compile presentation for the reviews


* Identify opportunities for improvement


* Present the information at the periodic reviews Monitor and trend metrics


* Identify and drive Quality Management System continuous improvement activities

Supplier Management


* Define and implement processes which meet regulatory requirements pertaining to the selection, evaluation, and monitoring of suppliers


* Create and/or maintain procedures to ensure that the organization complies with applicable regulatory standards


* Identify supplier risks and work with cross-functional teams to prevent and/or resolve issues which could interrupt business continuity


* Communicate critical issues to upper management and escalate accordingly


* Oversee and manage the execution of Supplier Quality responsibilities such as Supplier Audits, Supplier Qualifications.


* Schedule, plan and implement an effective internal and external Audit program.


* Manage Document Control and Training system.


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