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大手ヘルスケア企業でのSite QARA Leaderの求人

求人ID:105935

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転職求人情報

職種

品質管理

ポジション

Site Leader

おすすめ年齢

20代
30代
40代
50代以上

年収イメージ

年収イメージ:1200万円〜1600万円(経験・能力を考慮の上当社規定により決定)

仕事内容

外資系医療機器メーカーの日本法人における製造拠点(東京)での品質保証業務をリードいただきます。
日本およびグローバル/APACリージョンの製造部門および品質管理担当者と連携しながら、製品および製造プロセスにおける品質保証・規制対応を適切に展開するリーダーロールです。


1. Responsible for maintaining company certifications of Quality Management System like CE Mark, ISO 9001/ 13485, other countries regulations by correcting related issues.

2. Work for NPI closely with other functions (e.g. Marketing, Engineering, Manufacturing, Service) by reviewing and approving design Input/ Output. Sometimes, we lead engineering to improve issues found during the review.

3. Lead improvement activities per Quality Management System issues found by planning and executing external audit and internal audit.

4. Implement Global Quality Procedures in our company and maintain them with giving appropriate trainings.

5. Responsible for assuring quality of our final products. If any issue found, we’ll lead the improvement activities of issues and related processes.

6. Work for our customers with engineering by assessing customer complaints and giving necessary information to engineering.

7. Support and accelerate our suppliers to improve parts issues.

必要スキル

・ヘルスケア業界(医療機器メーカー、製薬等)における5年以上のQuality/Regulatory 関連(品質管理・保証、Regulatory Affairs)の業務経験
・ステークホルダーマネージメントおよび品質関連プロジェクトでリーダーシップを発揮した経験
・日本語力(母国語レベルもしくは業務上の複雑なディスカッション/プレゼンテーションが可能なレベル)および
英語力(グローバルチームとの円滑なコミュニケーションが可能なレベル)


1. Bachelor’s degree in Engineering, Medical Device Technology or Scientific Field (or High School diploma/GED and a minimum of 10 years work experience and understanding of product development, manufacturing, quality control and servicing in a medical equipment environment).

2. Minimum 5 years professional experience and understanding of product development, manufacturing, quality control and servicing in the medical equipment or pharmaceutical industry.

3. Minimum 3 years supervisory/ management experience, including hiring, training, coaching and performance management activities.

4. Hands-on experience with FDA, QSR, ISO, MDD and/or other international quality systems requirements.

5. Proven track record in performing external and internal audits.

6. Ability to read, analyze, and interpret business plans, technical procedures and governmental regulations.

7. Effective report, business correspondence and procedure writing skills.

8. Good problem identification, multivariable analysis and creative resolution aptitude.

9. Proven process development and project management skills.

10. Strong computer skills.

11. Ability to communicate using Japanese and English (TOEIC score higher than 700).

12. Communication/ Facilitation skills

1. Demonstrated experience working in a cross-functional environment and proven ability to influence and build consensus among multiple functions.
2. Experience in a global, matrix organization.
3. Team player with a global mindset.
4. Strong Change Acceleration skills.
5. Experience in building a Quality System from ground up.
6. Front line operational responsibility in Engineering, Manufacturing or Sourcing.

就業場所

就業形態

正社員

企業名

大手外資系医療機器メーカー

企業概要

大手外資系医療機器メーカー

企業PR

組織カテゴリ

備考

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