Senior Quality Specialist

Job description

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.