Quality Engineering Manager

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募集要項

会社概要

同社は医薬品、医療機器の開発を行っています。

業務内容

• Contribute to cross-functional project(s) as engineering expert.
• Communicate with external manufactures to improve / develop the medical devices.
• Build strong relationship with external partners.
• Compliance with Quality Policy and regulations

応募条件

• 3 + years Knowledge of relevant Medical Device industry.
• Knowledge of design control and risk management for Medical Device.
• Experience of through the product lifecycle of Medical Device including pre-market and post-market.
• Experience in the manufacture for medical devices.
• Experience in the creation of Quality Management System documents.
• Expertise in the mechanical design, polymer material and manufacturing engineering for medical devices are plus.
• Understanding of relevant regulations and guidelines, e.g. ISO13485, ISO9001, ISO14971 FDA 21 CFR Part 820.
• Very good communication and problem solution skill among global cross-functional team.
• Strong Communication skill with external parties.
• Business level of English.

給与

700 - 1000 万円

勤務地

東京