Specialists in Quality and Regulation - Cardiological Stents @ Gsap - February 202110 February 2021
Specialists in Quality and Regulation - Cardiological Stents
QA & RA Engineer with relevant experience with R&D activities and specifically TAVI (Transcatheter Aortic Valve Implantation) /Cardiology field.
Well experienced with ISO 13485, specifically Design controls and V&V activities.
Experienced with ISO 5840-3 and ISO 10555-X and other relevant standards.
Experienced with review/guidance for V&V Protocols, execution and reports for regulatory submission
Defining samples size/ support with protocol and execution discrepancies - while working according to companies’ procedures.
Generation of formal Quality documentation associated with the V&V execution
(not test execution)
Experiments raw data review.