Quality Assurance Director

求人詳細

The purpose of this role is to provide Quality and Regulatory expertise to support local/regional/international business objectives as well as provide guidance to employees to facilitate continuous quality improvement.
There are two primary roles:
1) critical in supporting the launch and lifecycle of commercialized products including localization, Distribution Center and Safety Management operations in compliance with Japanese regulations and Global QMS standards
2) ensures compliance with Quality System activities (programs, policies, processes, procedures) to achieve stated objectives.

Key Responsibilities:

• As Sokatsu (General Marketing Supervisor), is responsible for overseeing manufacturing, sales, and post-market safety management of medical devices. Ensure compliance with quality standards and take overall responsibility for product quality and safety.
• Maintains, advises and reports on compliance to Corporate Quality System, International and Local Requirements and Regulations as well as Quality Policies and Procedures to site Management Team and other employees on how to achieve compliance for the aforementioned Quality System elements, as applicable to the site;
• Promotes and develops quality awareness in every employee, while helping the site organization towards improved quality performance and ownership as well as customer and regulatory/compliance oriented initiatives;
• Monitors, identifies and reports on key Quality System indicators and takes appropriate action to address areas for improvement; May verify implementation of suggested solutions; Is responsible for continuous Quality System efficiency and effectiveness and promoting solution-driven behavior;
• Frequently interacts with and represents the quality function to certain departments like Operations, Regulatory, Sales and others, as key Quality System processes are managed by those areas (e.g. Complaint reporting, Field Action execution, etc) - May also interact with national regulatory authorities;

Quality System Requirements:

In all actions, demonstrates a primary commitment to patient safety and product quality by maintaining compliance to the Quality Policy and all other documented quality processes and procedures.
For those individuals that supervise others, the following statements are applicable:
• Assures that appropriate resources (personnel, tools, etc.) are maintained in order to assure Quality System compliance and adherence to the Quality Policy.
• Establishes and promotes a work environment that supports the Quality Policy and Quality System.

こんな方を求めています

経験・スキル

Key Requirements:
• Experienced Quality Director in a medium to large Medical Device Company; covers all aspects of QMS
• Experience leading Sr. Managers (results through other people leaders)
• Meets the qualifications of being a Sokatsu – previous experience preferred
• Expertise in MAH requirements/QMS Ordinance, ISO 13485, ISO 14971
• Strong English skills (both verbal and written)
• Track record of driving change in an organization
• Ability to think beyond “requirements” with ability to balance patient safety, quality, and business needs; innovative thinker
• Team builder – Good at helping to build community/develop talent/inspire
Strong collaboration skills – especially an ability to build partnerships with other functions

学歴

大学卒業以上

募集要項

職種

品質保証、品質管理

給与

年収 2,000 〜 2,850万円

賞与

-

雇用形態

正社員

雇用期間

期間の定めなし

試用期間

有り

就業時間

09:00～18:00

休日休暇

日曜日,土曜日,祝日
完全週休2日制(かつ土日祝日)、有給休暇10日～20日、休日日数124日 土日祝日、有給休暇、夏季休暇（5日）、年末年始休暇（12/29-1/4）、傷病休暇（5日）、永年勤続休暇（勤続5年ごとに5日）

保険

健康保険,厚生年金保険,雇用保険

待遇・福利厚生

退職金制度：勤続3年以上
各種トレーニング・人材開発プログラム、社内公募制度、目標管理評価制度、昇格制度
【その他】
■コア・ベネフィット・プラン：入院時医療費補助、長期収入サポート保険、定期健康診断(35歳以上は日帰り人間ドック)、自己啓発支援制度(上限10万円/年)、社員持ち株会、各種祝い金、ベネフィット・ステーション
■フレックス・ベネフィット・プラン：上乗せ保険、上乗せ自己啓発、スポーツクラブ費用、自宅用パソコン購入補助など

特長

上場企業, 外資系企業, フレックスタイム制, 年間休日120日以上, 完全週休2日制, 土日祝休み, 新規立上げメンバー, 語学力を活かす

業種

医療機器・医療品関連

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