Electrophysiology Software Quality Engineer - GMP Compliance

Abbott; Santiago de Querétaro; Presencial; MXN 420.000 - 640.000; Jornada completa

Descripción de la vacante

Abbott, a global healthcare leader, is expanding in Mexico with a new manufacturing facility in Querétaro. We are seeking a Software Quality Engineer to implement Electrophysiology software quality systems and ensure GMP compliance across documental systems and CAPA processes.

The role collaborates with Quality, Manufacturing and Engineering to sustain processes and meet regulatory requirements while driving KPIs like NCMRs and project milestones.

Formación

• 3 years of experience with computer applications (MES, INFOR, Power BI, and Excel).
• SAP knowledge is desirable.
• Intermediate to advanced English proficiency.

Responsabilidades

• Work in the implementation of Electrophysiology Software Quality Systems to ensure business/plant continuity through GMP compliance
• Support creation of software requirements, protocols, test plans, scripts, and reports to validate non-product software, using the non-product software development life cycle procedure and support process validation activities
• Identify, standardize and document software validations to meet current regulations and medical industry standards
• Provide guidance, maintain, leads and/or develops other software quality engineers in the Non-product software Lifecycle
• Apply the software quality methodologies to ensure that all non-product software adhere to regulations and standards
• Coordinate and ensuring software requirements and compliance with CFR21, FDA and other applicable regulations

Conocimientos

MES

INFOR

Power BI

Excel

SAP

Herramientas

CSV

Descripción del empleo

Abbott, a global healthcare leader, is expanding in Mexico with a new manufacturing facility in Querétaro. We are seeking a Software Quality Engineer to implement Electrophysiology software quality systems and ensure GMP compliance across documental systems and CAPA processes.

The role collaborates with Quality, Manufacturing and Engineering to sustain processes and meet regulatory requirements while driving KPIs like NCMRs and project milestones.