Wondering what's within Beckman Coulter Diagnostics? Take a closer look.
At first glance, you'll see that for more than 80 years we've been dedicated to advancing and optimizing the laboratory to move science and healthcare forward. Join a team where you can be heard, be supported, and always be yourself. We're building a culture that celebrates backgrounds, experiences, and perspectives of all our associates. Look again and you'll see we are invested in you, providing the opportunity to build a meaningful career, be creative, and try new things with the support you need to be successful.
Beckman Coulter Diagnostics is proud to work alongside a community of six fellow Diagnostics Companies at Danaher. Together, we're working at the pace of change to improve patient lives with diagnostic tools that address the world's biggest health challenges.
医療分析機器/検査機器の品質マネジメントシステムスペシャリスト
【ポジションの概要】
品質マネジメントシステムスペシャリストは、当社の医療分析機器/検査機器の品質マネジメントシステムの維持・管理を担当するポジションです。ベックマン・コールターの製品はグローバルマーケットを対象としており、三島事業所において製造・開発した分析装置を世界中に輸出しています。品質マネジメントのプロフェッショナルとして、グローバルメンバーとコミュニケーションを取りながら品質マネジメントシステムを整合させ、日本国内の品質マネジメントシステムの維持・管理を行っていただきます。
【ご担当いただく職務】
- 品質マネジメントシステムの内部監査の実施(内部監査員として)
- 品質マネジメントシステムの外部監査の支援
- 米国本社の品質プロセス担当者への報告・審議
- 品質マネジメントシステムのコミュニケーション活動の実施(品質システムマネジメントレビュー/品質会議
- 品質マネジメントシステムのプロセス改善活動の実施(手順書作成、従業員教育)
- 品質記録の管理
【求めるスキル・経験・知識】
- 大学卒業以上(学部不問)
- 品質分野での経験(5年以上)
- 医療機器、または医薬品の品質関連業務経験
- 薬機法、QSRおよび関連法規の知識
【語学力】
- 英語:中級レベル以上(読み書きと簡単なスピーキング力。社内での簡単な発表や質問ができる程度)
- 日本語:流暢レベル以上
【あれば尚可/歓迎するスキル・経験・知識】
- ISO 13485の主任監査員資格保有
【こういった方がご活躍いただけます】
- Critical Thinkingで物事を考えられる方。(前提条件にとらわれない方。)
- 目的意識をもって仕事に取り組める方。
- 自身の意見を表明し議論ができる方。
【ベックマン・コールター株式会社について】
ベックマン・コールター株式会社は、米国に本社を置き、世界各国でビジネスを展開するグローバルカンパニーです。臨床検査分野、ライフサイエンス分野という2つの分野で事業を構成しており、世界をより健康な場所にするために11,000人を超える社員が日々業務に取り組み、幅広い製品・サービス・ソリューションをご提供しています。
【就業条件】
採用企業: ベックマン・コールター株式会社
雇用形態: 正社員 試用期間: あり(3ヶ月間)
勤務地: 静岡県駿東郡長泉町東野454-32
最寄駅: 三島駅(JR東海道新幹線/東海道本線)、長泉なめり駅(JR御殿場線)
就業時間: 08:45~17:00(所定労働時間 7時間30分) 時間外勤務: あり
フレックス制度: あり。コアタイムなし
休日休暇: 完全週休2日制(土・日)、祝日、夏季休暇(3日間)、年末年始休暇(12月30日~1月3日)、会社創立記念日(7月第1週月曜日)
特別休暇: 生理休暇、結婚休暇、出産休暇、育児休暇、介護休暇、忌引き休暇
有休休暇: 入社日、もしくは4/1に付与(日数は入社月により変動)
社会保険: 完備(健康保険 厚生年金 雇用保険 労災保険)
通勤手当: 支給(委細は就業規則の定めによる)
定年制度: あり 定年再雇用制度: あり
退職金制度: 確定拠出年金、確定給付企業年金
受動喫煙対策: 建物内禁煙。敷地内に喫煙所あり
【福利厚生等】
- 慶弔見舞金制度
- 永年勤続表彰制度
- 福利厚生会社会員加入(国内、海外の宿泊施設やスポーツクラブ等の優待利用可能)
- 定期健康診断
【給与条件】
経験・スキルにより決定します。
グローバル共通のキャリアフレームワークに基づく魅力的な給与パッケージを用意しています。
Job Description in English
The Quality Management System Specialist for Beckman Coulter Diagnostics is responsible for Maintenance and management of the quality management system.
This position is part of the Beckman Coulter K.K., Global Business Quality Assurance & Regulatory Affairs located in Tokyo / Mishima and will be on-site. At Beckman Coulter, our vision is to relentlessly reimagine healthcare, one diagnosis at a time.
You will be a part of the Quality Management System team and report to the Manager of the Quality Management System team responsible for Maintenance and management of the quality management system. If you thrive in a Quality Management System improvement role and want to work to build a world-class Quality management System organization—read on.
In this role, you will have the opportunity to:
Conduct internal audit of the quality management system (as an internal auditor)
Support for external audits of the quality management system
Report and discussion to the person in charge of the quality process at the US headquarters
Conduct Communication activities of quality management system (Quality System Management Review/quality meeting
Conduct Quality management system process improvement (creation of procedure manuals and employee education)
Maintaining quality records
The essential requirements of the job include:
Education: Bachelor's degree
Experience: 5+years experiences in Quality field
Experience in maintaining and managing quality management system
Experience in quality-related work for medical devices or pharmaceuticals
Knowledge of the Pharmaceutical Affairs Low and related regulations
Work experience in English
Fluent Japanese skills
It would be a plus if you also possess previous experience in:
Lead Auditor qualification for ISO13485
Join our winning team today. Together, we'll accelerate the real-life impact of tomorrow's science and technology. We partner with customers across the globe to help them solve their most complex challenges, architecting solutions that bring the power of science to life.
For more information, visit
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