当社は、革新的な医療技術を通じて医療現場の課題解決に貢献するグローバルメドテック企業です。科学主導のアプローチと国際的なコラボレーションを基盤に、患者安全と医療の質向上を支える製品開発を推進しています。
Job Description
本ポジションでは、医療機器の ISO 13485 に基づく品質マネジメントシステム(QMS)の運用および改善を担当いただきます。QMS 文書の作成・改訂をはじめ、継続的なプロセス改善、手順書改訂、各種規制対応(事業許可取得、製造販売承認申請など)、製品の品質管理・安全管理(Vigilance)まで幅広い領域を担当します。
当社は製造を外部委託しているため、国内外の製造拠点やサプライヤーとの連携を通じ、品質監督を行うことも重要な役割です。また、海外子会社との協働も多く、グローバルな環境でQMS運用に関わることができます。
Why This Position?
- 製品ライフサイクル全体(開発初期〜製造〜市販後)に携わることが可能
- 外部製造拠点との協働により、幅広いQMS業務を経験
- 変更管理、CAPA、監査対応など幅広い品質業務を担当
- 海外グループとの連携により、国際的なQMS運用に貢献可能
- 拡大期における組織強化のための増員ポジション
Background for Hiring
事業拡大とグローバルな QMS 体制強化に伴う増員採用
Candidates Should Have
- 医療機器の製造販売業(MAH)業務に関する知識・実務経験
- 医療機器の品質管理・品質保証に関する経験
- 海外拠点とのやり取りが可能なビジネスレベルの英語力
May Also Bring
- 薬剤師免許
- 総括製造販売責任者/品質管理責任者/安全管理責任者の経験
- QSR / QMSR、EU MDR、ISO 13485 の深い知識
- ISO 13485 内部監査の実施経験
- 理系分野の学位またはバックグラウンド
Other Highlights
- 国際的なビジネス環境での勤務
- マネジメント業務なし
- 完全週休二日制(土日)
- フレックスタイム制度
- 平均残業 20 時間未満
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