QAマネージャー

Job Details

<職務内容>

・Support Quality Assurance supervisor to achieve Japan Commercial Operations objectives from Medical device perspective
・When Quality Assurance issue arises, lead to define the appropriate Quality measurement through the communication with the related internal, global and external parties.
・Ensure full compliance with applicable regulations in Japan.
・Oversee all activities or responsibilities that are delegated to external parties.

<Desired Education, Skills and Experience>
・5+years Knowledge of relevant in Quality Assurance in Medical Device industry. ・Experience of managing Medical Device class2 or3
・Experience of complaint handling
・Experience in both clinical and post-marketing environment.
・Understanding of PMD Act, relevant regulations and guidelines.
・Thorough knowledge of drug and medical device development process.
・Very good communication and problem solution skill among cross-functional team.
・Bachelor’s Degree in Science or related discipline
・Knowledge of relevant in Quality Assurance in pharma industry is plus.

※グローバルに展開する、革新的な治療技術プラットフォームを開発・提供するバイオテクノロジー企業です。

 

Job application

Apex delivers strong profile and highly skilled candidates that match the job description requirements. Their candidate know how, network and experience helped us to initiate contact and integrate the candidate into our company. We are very happy with the candidate selected by Apex. K.K. consulting service. Thank you for the professional recruitment consulting service throughout the selection and follow up. We really appreciated it and strongly recommend Apex.

APAC Head of Supply Chain

Global Healthcare Company