Senior Quality Specialist
1 mese fa
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 projectsâ 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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