Job Description
Descripción y detalle de las actividades
Duties include execution of all Incoming quality-related activities. This includes but is not limited to Quality System; Quality Engineering functions; Inspection activities, Gage Calibration and Document Control. Responsible for all Documentation Control activities associated with Quality System requirements, including Device History Records (DHR), Mexico Processes, employee training records, validations, and other Quality Records. Responsible for ongoing adherence to external regulations as required by the Food and Drug Administration GMP, ISO 13485 and other applicable regulations. Reviews and approves changes to local or external Instructions
Experiência y requisitos
Engineering degree3 Years minimum experience as an Incoming/Receiving Quality Engineer in a Medical Device Manufacturing companyKnowledge in the following fields:ISO13485Incoming InspectionInternal and supplier auditsProduct transfersProblem solving techniques (5whys, 8...
Duties include execution of all Incoming quality-related activities. This includes but is not limited to Quality System; Quality Engineering functions; Inspection activities, Gage Calibration and Document Control. Responsible for all Documentation Control activities associated with Quality System requirements, including Device History Records (DHR), Mexico Processes, employee training records, validations, and other Quality Records. Responsible for ongoing adherence to external regulations as required by the Food and Drug Administration GMP, ISO 13485 and other applicable regulations. Reviews and approves changes to local or external Instructions
Experiência y requisitos
Engineering degree3 Years minimum experience as an Incoming/Receiving Quality Engineer in a Medical Device Manufacturing companyKnowledge in the following fields:ISO13485Incoming InspectionInternal and supplier auditsProduct transfersProblem solving techniques (5whys, 8...
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