Description
We are looking for a
E-Device Quality Consultant (m/f)
Reference: -en
Start: asap
Duration: 6 MM
Place: in Geneva
Branch: Wettbewerber
Your tasks:
- Be the primary quality contact point for electromechanical medical devices (i.e. drug auto-injectors and connected accessories)
- Ensure design control compliance
- Identify applicable quality requirements and applicable standards
- Review and approve all project deliverables (internal and from suppliers)
- Participate in design reviews, approve/disapprove move to next phase
- Compile the Technical File, ensure CE mark approval
- Support medical device regulatory submissions worldwide
- Lead and execute the telecommunication registrations activities worldwide
- Lead the change control process
Your qualifications
- Business fluency in English
- Very good knowledge in electromechanical device industry and medical device industry
- Knowledge in ISO CFR 820, MDD 93/42/EEC and RED, RoHS2, WEEE2 Directives
Skills:
- Quality manager