Senior QA/RA Expert (ID1004)

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.