Description
We are looking for a
Consultant Quality Management (m/f)
Reference: -en
Start: asap
Duration: 6 MM
Place: in Coinsins
Branch: Wettbewerber
Your tasks:
- Provide support for quality system management
- Creation and update of SOPs
- Management of deviations (CAPAs)
- Documentation control
- Change control
- Maintenance of technical files
- Compilation and update of technical file to support the CE marking of class IIa (mechanical and electronic drug injection systems) and class I (software applications) medical device
- Update of risk management file for ISO 14971, essential requirements check-list and clinical evaluation report
- Collection and review of supplier documents
- Support international submissions
Your qualifications
- Good knowledge of quality systems
- Knowledge of ISO13485, 21 CFR 820, GMD guidelines
- Knowledge in CE marking of medical devices
Skills:
- Quality manager
Keywords: Qualitätsmanager