品質保証担当

1ヶ月前


Tokyo サスメド株式会社(SUSMED, Inc.)

サスメド株式会社は、デジタル医療のスタートアップで、Sustainable Medicine(持続可能な医療)の実現を目指し、保険適用対象となる不眠障害の治療用アプリの開発や、医薬品や医療機器の臨床試験/治験を効率化するプラットフォームの提供を行っています。

【業務内容】サスメドシステム(臨床試験の効率化のためのデジタルソリューション)及び治療用アプリの品質保証担当として、品質保証及び品質マネジメントをお任せできる方を募集します。

●医療機器のCSV関連業務の維持・管理、標準化推進・支援

●全社の品質マネジメントの維持・管理、標準化推進・支援

●製造販売後製品の品質保証及び品質管理

【チーム体制】

現在の組織構成:品質保証担当1名

事業拡大に向けた増員です。品質保証担当者1名と協働していただける方を募集します。

【キャリアイメージ】

入社後はプログラム医療機器である治療用アプリの品質保証業務、全社QMS管理を中心にスタートしていただき、将来的にはご経験やご希望に応じて、臨床試験の効率化のためのデジタルソリューションであるサスメドシステムの品質保証業務などへ領域を広げていただくことが可能です。

【必須スキル】

●製薬メーカー、医療機器メーカー、CROにおける品質保証、品質管理の業務経験が5年以上ある方

●医療機器のCSV関連業務の維持・管理、標準化推進・支援経験が5年以上ある方(JIS、IEC、ISOなど関連規制の精通)

【歓迎スキル】

●全社QMS体制の構築経験

●既存の手技・手法を踏襲しながらも、クリエイティブな方

●GCP・GPSP等の関連規制に関する知識を有し、臨床試験プロセス全般に精通している方



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