QA Assistant Manager

求人詳細

■About our Client
A leading global medical device company specializing in pain management and chronic care. The company is dedicated to improving patient outcomes through high-quality, innovative medical solutions and a robust global supply chain.

■Role Overview
The QA Assistant Manager supports the RAQA Manager in overseeing Quality Assurance operations in Japan. This role ensures compliance with the Japan PMD Act, QMS Ordinance (MHLW MO No.169), and ISO 13485 while acting as a key liaison with global quality teams.

■Main tasks include:
・Implementing and maintaining the QMS per Japanese regulations.
・Serving as Domestic Quality Assurance Manager when assigned.
・Overseeing complaint handling and product investigations (e.g., ETQ).
・Managing supplier quality and 3PL distribution partners.
・Leading preparations for PMDA inspections and corporate audits.
・Tracking CAPA implementation and ensuring timely closure.



#LI-Hybrid
#LI-KN

こんな方を求めています

経験・スキル

■Qualifications
・Minimum 7 years of experience in Quality Assurance in the medical device industry
・Strong knowledge of Quality Management Systems (QMS) and regulated environments
・Experience supporting audits and regulatory inspections
・Experience working with global teams in multinational organizations
・Ability to manage multiple quality activities simultaneously
・Business level proficiency in spoken and written English.

学歴

大学卒業以上

募集要項

職種

安全性管理、品質保証、品質管理

給与

年収 800 〜 900万円

賞与

Annual income + Incentive bonus (12.5%)

雇用形態

正社員

雇用期間

期間の定めなし

就業時間

09:00～18:00

休日休暇

土曜日　日曜日　祝日

保険

健康保険　厚生年金保険　雇用保険

受動喫煙防止措置

敷地内禁煙

業種

医療機器・医療品関連

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