Senior Specialist Quality Assurance - バスキュラー事業部

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PRIMARY FUNCTION / OBJECTIVE

 

[Quality Management System]

顧客の期待を超える品質基準で組織の開発と維持に参加し、社内および社外の顧客との活動を調整する。Participate in developing and maintaining the organization in the quality standard exceeding customer expectations and coordinates activities with internal and external customers.

PMD法の要件、AV およびアボットの企業ポリシー、および関連する AVJ 品質システム手順を遵守するための部門活動を実行する。Execute departmental activities for adherence to PMD Act requirements, AV and Abbott Corporate policies and relevant AVJ quality system procedures.

日本でのビジネスをサポートするための部門活動を実行する(例: 行政報告など)。Execute department activities for supporting business in Japan (e.g., Regulatory Reporting etc.).

品質保証関連の PMD 法の要求に応じて、適用されるすべての日本の規制機関に対して会社を代表する。Represent the company against all applicable Japanese regulatory bodies as required under Quality Assurance related PMD Act.

[Others]

顧客の期待を超える品質基準で組織を開発および維持し、内部および外部の顧客との活動を調整する。Develop and maintain the organization in the quality standard exceeding customer expectations and coordinates activities with internal and external customers.

日本でのビジネスをサポートするための部門の活動を管理する (例: 新製品の紹介)。Manage department activities for supporting business in Japan (e.g. new product introduction).

 

MAJOR RESPONSIBILITIES / ACCOUNTABILITY

[Quality Management System]

すべての活動が品質システム要件に準拠して実行されることを確実にする。Ensures that all activities are performed in compliance with quality system requirements.

品質保証活動を実施するために、医薬品医療機器等法、AV およびアボットの企業ポリシーに準拠して必要な手順の策定を支援する。Support developing and maintain the necessary procedures in compliance with PMD Act and AV and Abbott Corporate policies to perform Quality Assurance activities.

品質保証組織の開発を支援し、品質保証活動の効果的なリーダーシップを発揮し、医薬品医療機器等法および関連する会社の手順の遵守を監視する。Participate developing Quality Assurance organization, demonstrate effective leadership of Quality Assurance activities and monitor compliance with PMD Act and relevant company procedures.

安全および品質の測定に関して、上司に意見具申する。（例：製品不具合による重大な健康被害による製品回収）Provide recommendations to Line manager, regarding safety and/or quality measurement (e.g., product removal due to significant patient injury by product malfunction)

重大な製品不具合と品質保証活動の監視結果に関する情報を、上司に提供する。Provide information of significant product quality issue and results of monitoring Quality Assurance activities to Line manager.

以下の品質サブプロセスを含む主要な品質プロセスの開発、維持、または改善するために、実施または管理を行う。Implement or manage to develop, maintain, or improve following main quality processes including sub-processes.

・Management Responsibility 経営者の責任

・Purchasing Controls購買管理

・Change Management & Document Control 変更管理及び文書管理

・Product Approval (Marketing processes) 製品承認（マーケティングプロセス）

・Production &Process Controls (Sales &Distribution) 製造及び工程管理（販売及び流通）

・Improvement (Corrective and Preventive Action) 改善（是正及び予防措置）

・Post Market Support 市販後支援

[Others]

QSC他部署のインパクトゴールをサポートする。Support implementation of impact goals for another department of QSC.

OACA関連の活動に参加し、日本におけるOACAプロセス導入をサポートする。Participate in OACA-related activities and support the implementation of OACA processes in Japan.

EDUCATION, EXPERIENCE, KNOWLEDGE/SKILLS

 

- Required minimum formal education

大学等で、物理学、化学、生物学、工学、情報学、金属学、電気学、機械学、薬学、医学又は歯学に関する専門の課程を修了した者 Completed a specialized course in physics, chemistry, biology, engineering, informatics, metallurgy, electricity, mechanics, pharmacy, medicine, or dentistry at a university,.

- Preferred formal education

医学、薬学、科学または工学関連分野の 4 年制大学の学位と同等 4 years university degree of medical, pharmacology, scientific or engineering related fields.

 

PROFESSIONAL EXPERIENCE

Minimum Requirement

- 品質保証業務その他これに類する業務に３年以上従事した者であることEngaged in quality assurance work for 3 years or more.

Preferred Requirement

- プロジェクトリードもしくはグループリーダーレベルのマネジメント経験 Experiences in people management of the level of Group Leader or Project lead.

- バスキュラー製品の臨床使用に関する十分な知識 Good knowledge of clinical usage for Vascular products.

- 品質システムに関する十分な知識（ISO13585関連の主任監査員の有資格者など）Good knowledge of Quality System (i.e., Qualified Lead Auditor related ISO13485 etc.)

- 製品の設計製造工程に関する十分な知識 Good knowledge of product design and manufacturing process.

- ポータブルスキル (コミュニケーション, 論理的思考, プレゼンテーション, 交渉力, 及び問題解決能力) Portable/Transferable skills (Communication, Logical thinking, Presentation, Negotiation, and Problem solution skills)

- 医療機器の物流、サプライチェーンに関する十分な知識 Good knowledge of logistics and supply chains of medical device.

- 医薬品医療機器等法、QMSに関する十分な知識 Good knowledge of PMD Act. and QMS.

- 医療機器（委託販売）のビジネススタイルの十分な知識 Good knowledge of business style of medical device(consignment sales).

- ISO13585関連の主任監査員の有資格者など Qualified Lead Auditor related ISO13485 etc.

- 周囲によい影響を与える、イノベーションを促進する、イニシアティブを取る、結果を出す、関係構築 Inspire Others, Drive Innovation, Take Initiative, Deliver Results, Building relationship

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