仕事概要
職種 | 技術職(販売、設計、開発、生産管理)/生産管理、品質管理、施工管理、EHS、PMS |
---|---|
業種 | 医療/ その他医療 |
雇用形態 | 未分類 |
ポジションレベル | その他 |
募集人数 | 1名 |
希望入社時期 | - |
必須語学力 |
日本語 (流暢に話せるレベル) 英語 (ビジネスレベル) |
活かせる語学 | - |
勤務時間 | その他 |
福利厚生・休暇 | |
ビザ取得支援 | - |
外国人従業員 | - |
仕事詳細
Company Overview
Quality Assurance Manager - Top Global Medical Device Company
Job Description
Commercial QA Manager will lead the QA function in support of all Japan commercial operations. The role has direct management responsibility for 6 staff and plays as Domestic Quality Assurance Manager for Medical Device and IVD under PMD Act.
Specific Responsibilities :
• Manage the roles of Quality Control, Quality Assurance and Safety Control in Japan
• Support to achieve Japan Commercial Operations objectives from Quality Assurance perspective
• Maintain and continually improve the quality processes and procedures in Japan commercial operations
• Meet regulatory requirements and establishes policies and procedures.
• Communicate with overseas design and production facilities about quality and reliability problems which need to be solved. There are frequent interactions with manufacturing and engineering in addition to other relevant functional areas and operating entities.
• Ensure projects are completed on time within budget
• Strengthen the QA organization and develop members’ talents
Requirements
EDUCATION:
• Bachelor's degree in Science or equivalent
REQUIRED KNOWLEDGE AND EXPERIENCE:
• Minimum 5 years’ experience in Quality Assurance/Quality Control.
• Minimum 3 years’ experience in people management • Deep knowledge of PMD Act ( including related ministry ordinances ) • Deep knowledge of ISO13485
• Experience and/or knowledge of Medical Device / IVD industry
• Experience and/or knowledge of safety management role
• Native Japanese and Business level English (Frequent communication in English by e-mail, teleconference, etc.)
DESIRABLE KNOWLEDGE AND EXPERIENCE:
• Experience of MAH responsible persons (Sokatsu, Hinseki or Anseki)
• Experience of Medical product design, Service or manufacturing.
• Knowledge of “Risk Management Processes”
CERTIFICATION:
• ISO13485 Lead auditor
• Pharmacist
面接について
連絡先
QA Manager
RGFタレントソリューションズ株式会社
800 〜 1300 万円