Senior Quality Specialist

1 settimana fa


Milan, Italia Abbott A tempo pieno

Job description


Reporting to Manager QA , we are looking for a Sr Quality Assurance Specialist to joinour 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.



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