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Senior Quality Specialist  
■ポジション情報
NO JOB000026
業務内容 •Maintain Divisional Quality Management System in Komaki and Tokyo in accordance with global requirements.
•Have a responsibility of CAPA specialist.
•Have a responsibility of Training specialist.
•Support line Manager to plan, arrange and conduct periodical management review under DVQMS.
•Ensure high regulatory compliance with PMD Act. and QMS ordinance under Smiths Medical Divisional Policy at Tokyo head quarter and ten sales offices.
•Plan and conduct QMS and GVP education for employees including new hires.
•Conduct internal quality audit as a certified member.
•Support document control activity if required.
•Support regulatory activities if required.
•Keep good communication with GQR and each function within SMJ.
勤務地 東京都
経験・知識 •High level of knowledge of Japanese PMD Act., related law and medical device of company products are required.
•Experience working with quality assurance is required.
スキル・資質 •Strong communication skills (written and verbal) as the role involve liaising at different levels.
•Strong ability to multi tasks in parallel and high attention to details.
•Take responsibility for the assigned tasks.
•Think “out of the box” to meet with continuous improvement requirements.
•Good analytical skills
学歴・免許・資格
•Educational requirements – Bachelor’s degree in Science, Chemical or Engineering areas with a minimum of 5 years’ experience in Medical Devices, or equivalent.
語学力
•High verbal and e-mail communication ability in English (a TOEIC score of more than 700 preferable).
■企業情報
会社名 スミスメディカル・ジャパン株式会社
事業内容 医療用機器・器具の輸入・製造・販売およびそれに関わるサービス業務
従業員数 220名
企業の特徴 英国に本社を置く、医療分野の世界的なリーディング・カンパニー。主にクリティカルケアや集中治療、麻酔、および在宅看護で使用される医療機器・安全器材の製造・販売を専門とし、英国をはじめ、米国、日本、欧州諸国、東南アジア、オセアニア、南アフリカでビジネスを展開しています。
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