QMS 13485 Auditor

🕒 February 16

🗣️🇯🇵 Japanese Required

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Logo of BSI

BSI

1001 - 5000 employees

Founded 1901

📋 Compliance

Compliance • Healthcare • Sustainability

BSI is a global Standards organization committed to helping organizations improve their performance and ensure safety, quality, and sustainability. As the UK National Standards Body, BSI provides a wide range of services, including certification, training, and assessment across various sectors such as healthcare, construction, and energy. BSI empowers businesses to adopt best practices and drive positive change through robust standards development and innovative solutions for a resilient digital future.

📋 Description

• ISO 13485品質マネジメントシステムの監査を実施 • 医療機器の設計、製造の実務経験を基に監査を実施 • 監査報告を作成し、計画チームと調整 • 医療機器メーカーとのコミュニケーション

🎯 Requirements

• 4年以上医療機器の設計または製造に直接責任を持った経験 • 理系分野での学位 • ISO 13485、MDSAP、MDRの知識 • 品質マネジメントシステムの環境での2年以上の経験 • 日本語と英語での流暢な話しや書き能力

🏖️ Benefits

• 通勤費 • 各種社会保険 • 賞与:業績連動型 • 給与見直し(年1回) • 企業型確定拠出年金(60歳未満の正社員対象)

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