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Medical Device Auditor - Japan / 医療機器品質マネジメントシステム監査人

Medical Device Auditor - Japan / 医療機器品質マネジメントシステム監査人

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Medical Device Auditor - Japan / 医療機器品質マネジメントシステム監査人

Medical Device Auditor / 医療機器品質マネジメントシステム監査人
Japan (home based)

医療サービス・IVDに関する知識と経験を活かして、日本の医療の安全を守る道を歩みませんか?

私たちのクライアントは、クライアントが直面する潜在的な課題に精通している専門家になるために、最高の審査員の採用とトレーニングに多額の投資をしています。当社の監査人はまた、グローバル顧客満足度調査で非常に高いスコアを獲得しており、最高品質の監査を提供しています。

Do you want to build on the experience you have and learn what it really takes to get a device on to the market? Have you ever considered working for a notified body? MSI Pharma are representing a market leading MDR/ IVDR designated notified body who continues to grow. We are looking for individuals interested in a career as a Lead Medical Device Auditor and benefit from industry leading training and development.

Medical Device Auditors evaluate the quality management standard of ISO 13485 systems on our clients' sites. The Medical Device Auditor is a client facing role and requires significant travel domestically within Japan

This role would allow you to work with different products and different manufacturers almost daily. This notified body works with the biggest names to small start ups working on a product that is going to revolutionise the industry. No two days would be the same!


Core Responsibilities:

  • Evaluate the quality management standard of ISO 13485 systems and CE marking / ISO 13485 / CEマーキング 審査における審査業務
  • Writing and communicating your conclusions via understandable and clear reports and presenting them to clients.

Requirements:

  • Bachelors, Masters or PhD in relevant science or engineering / 大卒以上の学歴(電気・電子・またはITシステム工学を専攻していること)
  • 4+ years medical device experience / 能動医療機器メーカーでの設計開発、製造、品質保証のいずれかの実務経験
  • Work experience can be within: Research and development, manufacturing, service, testing / 製造、または品質保証における実務経験
  • 2+ years working in a quality management environment / ISO13485の知識
  • Domestic travel (when possible) / トラベル
  • Fluent Japanese with an understanding of English / 英語力(ビジネス文書の読解)