QMS Manager

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Job details

Company overview

Our client is a global medical device manufacturer.

Responsibilities

医療機器製造販売業のQMS体制の運用担当者（国内品質業務運営責任者）に加え、下記業務をお願いします

• 安全管理/品質保証業務について、QMS省令に基づいた組織体制の構築
• 国内QMS責任者として海外生産拠点との折衝・監査・オーディット・登録業務
• 監督官庁・PMDAとの折衝業務
• 海外の製造所からのドキュメント情報入手と精査

In addition to being in charge of operating the QMS system for a medical device manufacturer and distributor (domestic quality operations manager), you will also be required to perform the following duties:

• Establish an organizational structure based on the QMS Ministerial Ordinance for safety management/quality assurance operations
• Negotiations, audits, and registration work with overseas production bases as the domestic QMS manager
• Negotiations with supervisory authorities and the PMDA
• Acquisition and review of document information from overseas manufacturing sites

Requirements

必須条件:

• 医療機器のQMS経験（クラスⅣ：高度管理医療機器の経験者歓迎、生物由来製品取扱い経験あれば尚可）
• チームリーダーやマネジメントの経験
• ビジネスレベルの英語力（目安：TOEIC 900点以上）

Required qualifications:

• Experience with QMS for medical devices (Class IV: Experience with highly-regulated medical devices is preferred, experience with biological products is preferred)
• Experience as a team leader or manager
• Business-level English skills (Recommendation: TOEIC 900 or above)

Salary

7 - 15 million yen

Location

Tokyo