Reporting to Manager QA , we are looking for a Sr 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.
T he 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
Italy > Milan : Viale Edison 110, Edison Park Centre
SIGNIFICANT WORK ACTIVITIES: