Senior Quality Specialist

Job description

JOB DESCRIPTION:

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.

     

The base pay for this position is
N/A

In specific locations, the pay range may vary from the range posted.

     

JOB FAMILY:

Operations Quality

     

DIVISION:

HIAC Core Lab

        

LOCATION:

Italy > Milan : Viale Edison 110, Edison Park Centre

     

ADDITIONAL LOCATIONS:

     

WORK SHIFT:

Standard

     

TRAVEL:

Not specified

     

MEDICAL SURVEILLANCE:

Not Applicable

     

SIGNIFICANT WORK ACTIVITIES:

Not Applicable