Assistance in implementation of a quality management system in compliance with ISO 13485:2016 and FDA requirements

Support Design and Development activities in different stages: design input, output, V&V

Updating the DHF

Assistance in V&V planning and execution ( Biocompatibility, performance, packaging, transportation, shelf life and sterilization validation )

Participation in risk management ( DFMEA, AFMEA, PFMEA )

Design transfer and DMR

Incoming inspection

Suppliers’ evaluation

Document control

Preparation for external audits

Support ECO’s

Support CAPA’s

Support clinical trials

Assistance in bench tests, validation testing and prototypes manufacturing

Qualifications

3 years of QA experience in the medical device industry (design control experience is an advantage)

BSc in Bio-Medical/ Mechanical /Biotechnology Engineering / Exact Sciences

Strong written and verbal communication skills in English