Demant Operations, S.A. de C.V.
Quality Engineer
Job Description
Descripción y detalle de las actividades
Duties include execution of all 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), 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 documentation changes RESPONSIBILITIES: - Reviews Customer Complaints/Returns and provides reports as required. - Remake, Repair and Return reports - Maintains product quality by enforcing quality assurance policies and procedures and government requirements. - Coordinates and maintains compliance to ISO 13485 requirements. - Maintain MDSAP requirements. - Oversees co...
Duties include execution of all 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), 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 documentation changes RESPONSIBILITIES: - Reviews Customer Complaints/Returns and provides reports as required. - Remake, Repair and Return reports - Maintains product quality by enforcing quality assurance policies and procedures and government requirements. - Coordinates and maintains compliance to ISO 13485 requirements. - Maintain MDSAP requirements. - Oversees co...
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