Software Quality Engineer – GMP Compliance (MedTech)

Abbott Laboratories; Santiago de Querétaro; Presencial; MXN 480.000 - 720.000; Jornada completa

Descripción de la vacante

Abbott Laboratories in Querétaro is seeking a Software Quality Engineer to help implement GMP-compliant software quality systems within our Electrophysiology (EP) manufacturing initiative. You will collaborate with Quality, Manufacturing and Engineering to sustain projects and ensure adherence to regulatory standards.

The role requires experience with software quality processes, validation activities and cross-functional leadership, along with a strong English proficiency and exposure to

Formación

• 3 years of experience working with computer applications (MES, INFOR, Power BI, and Excel).
• SAP knowledge is desirable.
• 1 year of experience in Quality-related positions.
• 1 year of project management experience.
• 2 years of experience in regulated industries (pharmaceutical, food, or cosmetics).
• 2 years of experience in CSV projects, with involvement from Design Qualification through maintenance of the validated state.

Responsabilidades

• Implement Electrophysiology Software Quality Systems to ensure GMP compliance.
• Support creation of software requirements, protocols, tests, scripts and reports for validating non-product software.
• Provide guidance and leadership to other software quality engineers.
• Coordinate software requirements and compliance with CFR21, FDA and other regulations.

Conocimientos

English proficiency

Herramientas

MES

INFOR

Power BI

Excel

SAP

Descripción del empleo

Abbott Laboratories in Querétaro is seeking a Software Quality Engineer to help implement GMP-compliant software quality systems within our Electrophysiology (EP) manufacturing initiative. You will collaborate with Quality, Manufacturing and Engineering to sustain projects and ensure adherence to regulatory standards.

The role requires experience with software quality processes, validation activities and cross-functional leadership, along with a strong English proficiency and exposure to