**Reporting to Manager QA , we are looking for a** **Quality Assurance Specialist** **to join** **our** **team in Italy.**
+ Create / update QMS documentation in accordance with correspondent regulations, ISO standards and FDA guidelines and Abbott Division procedures;
+ Participate in projects’ meetings and manage / review project documentation (User Needs, Requirements, Verification Plans, Protocols, Reports, Risk Management Plans, Reports and etc.) according to correspondent standards, regulations and QMS procedures;
+ Support of internal/external audits;
+ Manage Product Defect tickets, CAPA, Non-conformances, customer complaints.
+ Bachelor degree in biomedical engineering, Computer science or equivalent or equivalent
+ Good knowledge of MS Office products;
+ Min 2 years of experience in Med. Device manufacturing and service area;
+ Knowledge of ISO9001, ISO13485, IEC62304 and FDA guidelines. Knowledge of ISO 27001, ISO14971 and CE regulations is an advantage;
+ Fluent English language and negotiation skills (oral & written).
**Geography** : the position will be based in Milan.
The willingness to fully **relocate in the proximity of the office** is, therefore, a necessary **requirement** .
Do you like the sound of this job and think you’ve got what it takes? Then send us your CV today. We look forward to receiving your application **as pdf**
An Equal Opportunity Employer
Abbot welcomes and encourages diversity in our workforce.
We provide reasonable accommodation to qualified individuals with disabilities.
To request accommodation, please call 224-667-4913 or email email@example.com