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QC Associate Manager - Tier 1 Medical Device Company

International Company w/strong pipeline

職種品質保証・品質管理
給与 700 - 900 万円
日付2019-08-22
業種医療用具
勤務地東京
求人番号Job-00095175

会社概要:

Our client is a joint venture of US medical equipment manufacturer and a major Japanese pharmaceutical company.

業務内容:

Reports to: Quality Assurance Senior Director
Department: QC Department
Location: Tokyo

Job description:
- 3PL warehouse, product introduction, quality-related issues from product receipt to delivery.

Main functions:
- Thorough compliance with quality assurance contracts related to 3PL warehouse and service center, Bard warehouse and service
- Corporate, company, and law and standard requirements and to maintain
- Maintain QC department's and ISO documents.
- Implement improvements on a continuous basis.
- To solve quality problems of accepted products, quality problems in 3PL warehouse, quality problems related to domestic product shipment.
- Verify implementation of the solution to the above quality problem and take necessary action to prevent the recurrence of the problem.
- Continue to maintain compliance in cooperation with each person in charge.
- Develop and implement education and training programs for employees as necessary.
- Deviated from requirement criteria
- Ensure that batch documents are being reviewed. If there is no problem, approve the release of the product.
- Ensure that all manufacturing-related deliverables are subject to specified quality requirements. In addition, it is influenced by consolidated information
- And planning and reviewing test items and advising methods and equipment used for testing and inspection

 

応募条件:

- Science Background
- Work experience with regulatory authorities (PMDA, ISO certification body, etc.)
- ISO 13485 standard and all related regulations, standards
- Various oral and written communications, presentation skills, customer-oriented attitudes, professionalism
- Business travel - for training seminars (5-10 days/year)
- English ability

Preferred:
- supplier audit, quality management system 
audit experience


BRS Consultant

Karla Santos

Medical Device

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    概要:

    ネットワーク、ITサービス、IT製品、社会インフラ事業、個人向けソリューション、電子機器の開発および販売を行っている大手企業です。

  • 安全管理- Tier 1, extensive product pipeline

    Tier 1 Company with many products

    職種品質保証・品質管理
    給与 600 - 800 万円
    日付2019-07-01
    業種医療用具
    勤務地東京
    求人番号Job-00075321

    概要:

    The company is one of the world's largest providers for products and support instruments for the medical industry.

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    世界最大級のヘルスケアカンパニーです。

    職種品質保証・品質管理
    給与 800 - 1200 万円
    日付2018-08-15
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    勤務地東京
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    概要:

    医療機器のリーディングカンパニーとして世界的に有名な企業です。