【医療機器ISO13485審査員】home based
72% Flex- Remote from:Japan
【医療機器ISO13485審査員】home based
Offer summary
Qualifications: University degree or equivalent, Knowledge of domestic regulations and English language proficiency.
Key responsabilities:
- Ensure adherence to required audit processes related to ISO13485 certification without compromising independence and neutrality
- Practicing Excellence Behaviours and supporting trainee auditors in their tasks
Job description
Your missionsGreat that you're thinking about a career with BSI!
Purpose of Position
ISO13485審査部業務に適合した審査プロセスの遂行に責任を負う。
Key Responsibilities & Accountabilities
- 審査手順・指示に従い、認証機関としての、独立性・中立性に関して妥協せず、ISO13485審査、及び関連サービスを確実に実施する。
- 割り当てられた業務 (審査及びその他支援業務）の確実な遂行
- Excellence Behavioursの実践
- トレーニー審査員へのサポート
- 審査業務において顧客及び社内関係部署との連携を図る。
- BSIのコアバリュー/エクセレンスビヘイビアーに従って行動する。
Key Performance Indicators
- PDR
Knowledge / Skills / Abilities
- 大学卒業又は同等の学歴
- 国内規制対応であるが、英語の読み書き及び会話能力があればなお良い
- 薬機法認証業務に関連する法規制等に対する知識
- 熱心で献身的なチームプレイヤ
- 優れたタイムマネジメント能力で自己の業務管理を遂行できる、
- 自発的で柔軟な姿勢
- 業務システム等の十分なITスキル
- 顧客及び社内関係者との良好なコミュニケーションを構築できる能力
Our Excellence Behaviours: Client-centric, Agile, Collaborative. These three behaviours represent how we do things at BSI. They help us ensure that BSI is a great place to work and a highly successful business.
BSI is conducting face-to-face interviews where appropriate and possible. If you are invited to a face-to-face interview but feel more comfortable with conducting the interview virtually, please speak to a member of our recruitment team.
Required profile
- Enthusiastic team player with dedication
- Excellent time management skills and proactive approach
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