Senior Quality Specialist

Job descriptionReporting to Manager QA , we are looking for aSr Quality Assurance Specialistto joinour team in Italy.Major AccountabilitiesCreate / 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.EducationBachelor degree in biomedical engineering, Computer science or equivalent or equivalentBackgroundGood 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. #J-18808-Ljbffr