Reporting to Manager QA , we are looking for a Sr Quality Assurance Specialist to join our team in Italy.

Major Accountabilities

• 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.

Education

• Bachelor degree in biomedical engineering, Computer science or equivalent or equivalent

Background

• 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