主な職務 シニア 品質オペレ-ションエンジニア / スペシャリストは,以下のクオリティオペレ-ション関連業務をリ-ドする。 • アビオメッドのグロ-バルチ-ム( QA ,製造エンジニア,サプライヤ-品質など)と連携し,製品に関連するすべての不適合とその調査をリ-ドする。 • 顧客に影響を与える問題を処理し,品質とコンプライアンスを考慮した解決策を優先する。 • 製品に関連する不適合および CAPA をすみやかに完了させることに責任を持つ。 • 3PL (サ-ドパ-ティロジスティクス)における受入検査,製品リリ-ス,保管関連業務の管理 主要な QMS プロセス(不適合管理, CAPA など)の改善 必要とされる経験,スキル等 医療機器メ-カ-での品質保証業務に 3 年以上従事した経験,またはそれに準ずる経験 医薬品医療機器等法( PMD 法)及び QMS 省令に関する基礎知識 高いコミュニケ-ション能力と問題解決能力 日本語および英語での文書作成およびコミュニケ-ションスキル 基本的なパソコンスキル( Microsoft Word
主な職務 品質保証シニアスペシャリストは,品質保証関連業務全般を行う。 • 品質等に関する情報,品質不良等の処理および管理(不適合管理) • 製品標準書の作成,維持管理 • 製品に係る変更管理 • 海外製造所および最終製品保管の製造所との協働 • 製品の受入れ検査,市場への出荷可否判定等の管理 • 回収処理 • QMS 適合性調査の対応 • 業態管理(製造販売業,販売•業貸与業の許可および更新,外国製造所の登録および更新) 必要とされる経験,スキル等 - 医療機器関連会社における 3 年以上の品質保証関連業務の経験,あるいは同等の経験 - 薬機法, QMS 省令の基礎的な知識 - 日本語および英語文書およびコミュニケ-ションレベル 基礎的な PC ( Microsoft Excel , Word
Who We Are At Kyndryl, we design, build, manage and modernize the mission-critical technology systems that the world depends on every day. So why work at Kyndryl? We are always moving forward – always pushing ourselves
Who We Are At Kyndryl, we design, build, manage and modernize the mission-critical technology systems that the world depends on every day. So why work at Kyndryl? We are always moving forward – always pushing ourselves
Who We Are At Kyndryl, we design, build, manage and modernize the mission-critical technology systems that the world depends on every day. So why work at Kyndryl? We are always moving forward – always pushing ourselves
Who We Are At Kyndryl, we design, build, manage and modernize the mission-critical technology systems that the world depends on every day. So why work at Kyndryl? We are always moving forward – always pushing ourselves
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Who We Are At Kyndryl, we design, build, manage and modernize the mission-critical technology systems that the world depends on every day. So why work at Kyndryl? We are always moving forward – always pushing ourselves
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Who We Are At Kyndryl, we design, build, manage and modernize the mission-critical technology systems that the world depends on every day. So why work at Kyndryl? We are always moving forward – always pushing ourselves
Who We Are At Kyndryl, we design, build, manage and modernize the mission-critical technology systems that the world depends on every day. So why work at Kyndryl? We are always moving forward – always pushing ourselves
Who We Are At Kyndryl, we design, build, manage and modernize the mission-critical technology systems that the world depends on every day. So why work at Kyndryl? We are always moving forward – always pushing ourselves
Who We Are At Kyndryl, we design, build, manage and modernize the mission-critical technology systems that the world depends on every day. So why work at Kyndryl? We are always moving forward – always pushing ourselves
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Who We Are At Kyndryl, we design, build, manage and modernize the mission-critical technology systems that the world depends on every day. So why work at Kyndryl? We are always moving forward – always pushing ourselves
Who We Are At Kyndryl, we design, build, manage and modernize the mission-critical technology systems that the world depends on every day. So why work at Kyndryl? We are always moving forward – always pushing ourselves
