Jr Quality Systems Engineer

Descripción y detalle de las actividades
JOB SUMMARY:
Supports Quality System compliance by
managing the Internal Audit process, Document and Record Control and CAPA
system.

ESSENTIAL DUTIES AND
RESPONSIBILITIES: – Other duties may be assigned:
•Ensure compliance with QSR part 820, ISO-13485 and other applicable regulations.Performs other duties as requested.
•Ensure Quality Key Performance Indicators at plant level and prepare presentations at corporate level.
•Ensures the administration of CAPA's administration system (TW8) in account generation, providing training in its use, as well as monitoring the user accounts releasing.
•Administrate Audit system (TW9) in generating accounts, provide training in its use, as well as monitoring the user accounts releasing.
•Coordinate product audits.
•Coordinate and respond to site regulatory matters or requirements.
•Responsible Quality Culture Program for the site, that consist: Quality Week, Quality Messages, Training in quality culture and follow up to the Quality Hero program.
•Provide training in the Quality system, such as: Good manufacturing practices at an indirect and direct personnel.
•Document Control Coordination responsable of:
•Periodic Review to Quality System Documents.
•Review of the correct release of engineering changes through the implementation plan.
• Create and follow up to changes of Quality System Documents.
•Send weekly notifications of the releasing of quality system documents changes.
•Responsible of Records Storage.
•Responsable of the coordination for the controlled copies distribution.
•Document Matrix Maintenance.

Experiencia y requisitos
Educación requerida – Education required:
B.S. Degree in Engineering.
Experiencia deseable – Desirable experience:
•Knowledge of Quality system audits (internal and external).
•Knowledge of CAPA's and root cause investigation tools.
•1-3 years of experience as quality or Quality System engineer.
•Knowledge in ISO 13485 and 21 CFR Part 820.
•Use of Microsoft Office.
•Knowledge desirable on systems such as: SAP, Trackwise, Power BI.
Bilingual:Oral and written communication in English.
Beneficios
Beneficios de acuerdo a la LFT
seguro de vida
comedor
fondo de ahorro
seguro de gastos médicos
plan de indexación
servicios médicos en planta