Job Information
J&J Family of Companies [Abiomed] Quality Systems Manager, Quality Assurance in Japan
[Abiomed] Quality Systems Manager, Quality Assurance - 2406179608W
Description
Job Responsibilities:
Quality System manager represents the company as a person responsible for overseeing the company’s quality management system which are complying with the Japan regulations and also meeting the requirements of company policies and systems.
Quality System manager works at Tokyo Office and reports to Quality Director.
Principle Duties and Responsibilities :
Manage, maintain, and improve the Quality Management System (QMS)
Manage QMS documents, records, etc.
Lead, maintain and manage the implementation of QMS-related IT Systems
Respond to internal quality system audits and external audits (e.g., audits/inspections by health authorities and the US headquarters).
Performing internal and external audits including supplier audits
Controlling QMS related training activities
Qualifications
2 years of experience as a manager or a supervisor
5 years of experience in Quality Assurance or Quality System related work in a medical device industry or equivalent
Good knowledge of Japan PMD Act, QMS Ordinance and ISO13485: 2016
Business level English
Basic PC skills (Excel, Word, PowerPoint, PDF etc.)
Experience working for foreign medical device companies.
Knowledge of cardiac related medical device products (Class VI)
Experience leading projects, including improvement initiatives.
People management experience
Work Location - 2-chome Nihonbashi Muromachi, Chuo-ku, Tokyo
Primary Location Asia Pacific-Japan
Organization Abiomed Japan K.K. Legal Entity
Job Function Quality Systems
Req ID: 2406179608W