Sagamihara, Japan | Full-time
A leading global healthcare manufacturing organization is seeking a Quality Engineer to join its production site in Sagamihara.
The company specializes in the manufacturing of hard capsules used in pharmaceuticals and nutritional supplements, providing high-quality products and end-to-end technical support as a total solutions provider.
Key ResponsibilitiesDefine and agree on product quality specifications with customers.
Maintain and continuously improve the quality management system.
Manage and respond to customer quality complaints, inquiries, and audits.
Collect quality data and provide feedback to the production site for process improvement.
Required Qualifications
Minimum 3 years of experience in quality assurance within the healthcare, pharmaceutical, or food manufacturing industry.
Working knowledge and hands-on experience with ISO 9001, GMP, and HACCP standards.
Strong problem-solving and goal-achievement skills.
Excellent communication skills in Japanese.
Preferred Skills
Ability to communicate effectively in English (sufficient for meetings or hosting international visitors).
Management or leadership experience is a plus.
Ideal Profile
Proactive and growth-oriented, with a strong sense of ownership.
Capable of effective cross-functional communication.
Skilled at collaborating with international teams.
Customer-focused, resilient, and compliant with safety and environmental standards.
Education
Bachelor's degree or higher (any discipline).
当事業部は、医薬品・健康食品に使用されるハード・カプセルを製造するメーカーです。
お客様に対して高品質の製品だけではなく、グローバルネットワークを活かした技術並びにマーケットトレンドを提供すると共に、お客様の技術サポート等、トータルソリューション・プロバイダーとして付加価値の高いサービスを提供しています。
バイオ医薬品及び健康食品分野へ、多様で革新的な剤形の設計から開発及び製造までをおこなっており、サイエンス、テクノロジー、処方及びカプセル専門というユニークな組合せにより、お客様にとって、バイオアベイラビリティ、ターゲットデリバリー、商品パフォーマンスの最適化を可能とします。当社は、斬新で、高品質な、進化し続けるニーズに応えるソリューションを創造するためのお客様とのパートナーであり、患者及び消費者にとってのベネフィットを提供いたします。
【業務内容】
・顧客との製品規格の取り決め
・品質システム維持管理
・顧客からの品質クレーム、問い合わせ、監査への対応
・品質情報の収集と生産工場へのフィードバック
【必須経験/スキル】
・ヘルスケア業界(医薬品、食品等)での製品工場にて3年以上の品質保証業務経験
・ISO9001、GMP、HACCPに関する知識及び実務経験
・問題把握、問題解決能力
・目標達成能力
・日本語でのコミュニケーション能力
【歓迎スキル】
・英語でのコミュニケーション能力:
外国人とアテンドが可能なレベル(TOEIC点数は関係なく自己申告で可)
・マネジメントのスキル
【求める人物像】
・自ら考え、成長できる
・組織横断的なコミュニケーション能力
・海外拠点との情報共有と相互協力
・カスタマーフォーカス
・ストレス耐性がある
・安全・衛生・環境管理、コンプライアンス遵守
【必要資格】
大学卒以上(専攻は不問)
【勤務時間】
8時15分~16時45分または9時~17時15分(実労働時間 7時間25分、休憩65分)
※時差勤務制/各人の申請と上長の承認により選択可
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