Senior QA/RA Expert (ID1004)
100,00 kr.
Eva Steinick
Umeå university, Lund university
Competences:
- Project management.
- Quality management.
- Management Representative.
- Gap Analyses.
- Quality systems implementation.
- Design Control.
- Design Dossiers and Technical File forCE marking.
- Preparation and submission of int.l registrations for Class IIa, IIb and Class III medical devices and for IVDs.
- Trained Lead auditor; supplier audits, internal audits.
- Risk Management, Complaints, CAPAs.
- Software Validation.
- Change Control.
- Vigilance.
- FSCAs.
