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部署・役職名 | [Abiomed] Quality Systems Manager, Quality Assurance |
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職種 | |
業種 | |
勤務地 | |
仕事内容 |
■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 |
応募資格 |
【必須(MUST)】 2+ years of experience as a manager or a supervisor5+ 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.) Basic PC skills (Excel, Word, PowerPoint, PDF etc.) 【歓迎(WANT)】 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 |
受動喫煙対策 | その他 「就業場所が屋外である」、「就業場所によって対策内容が異なる」、「対策内容は採用時までに通知する」 などの場合がその他となります。面接時に詳しい内容をご確認ください |
更新日 | 2024/12/07 |
求人番号 | 3606088 |
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