投稿日：2024/01/18
（社名非公開）
Sustaining & Quality Engineering Manager
ポジション情報
| 職種 | 研究開発 |
|---|---|
| 雇用形態 | 正社員（期間の定め無し） |
| 勤務地 | 東京都 |
| 給与 | 800万円～1400万円 |
| 給与（詳細） | スキル・経験をもとに優遇 |
| 職務内容 | 【Position overview】 This position will directly report to Associate Director of Sustaining and Quality Engineering to lead the design control and risk management of our medical devise. 【Key Duties and Responsibilities】 ○ 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 |
| 応募資格 | ○ 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. ○ Bachelor's Degree in Engineering or related discipline ○ Strong Communication skill with external parties. ○ Business level of English. |
企業情報
| 募集企業 | （社名非公開） |
|---|
