Software Quality Engineer – Medical Device GMP Compliance

Abbott; Santiago de Querétaro; Presencial; MXN 420.000 - 620.000; Jornada completa

Descripción de la vacante

Abbott in Querétaro is seeking a Software Quality Engineer to support Electrophysiology software quality systems and ensure GMP compliance in a manufacturing setting.

You will work with Quality, Manufacturing and Engineering on sustaining activities, coordinating software requirements, validations and CAPA to meet regulatory standards. This role offers growth within a global healthcare leader and exposure to CFR21/FDA requirements.

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.
• Intermediate to advanced English proficiency.

Responsabilidades

• List the main responsibilities this job position regularly performs
• 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, qualification, working with multidisciplinary areas
• Identify, standardize and document software validations to meet current regulations and medical industry standards
• Provides guidance, maintain, leads and/or develops other software quality engineers in the Non product software Lifecyle.
• Apply the software quality methodologies to ensure that all non-product software adhere to regulations and standards
• Works closely with Quality, Manufacturing, IT, Microbiology, Calibration, and Engineering on sustaining and projects activities to ensure compliance with the quality system requirements
• Provide guidance and understanding of the quality management system procedures (related with software), as well as support to ensure compliance with current regulatory requirements. It will offer coaching and support to achieve objectives and may provide feedback or elevate situations if internal and/or regulatory requirements and policies are not met.
• Coordinate, approve and ensuring software requirements and compliance with CFR21, FDA and other applicable regulations

Conocimientos

Power BI

Excel

English proficiency

Herramientas

SAP

Descripción del empleo

Abbott in Querétaro is seeking a Software Quality Engineer to support Electrophysiology software quality systems and ensure GMP compliance in a manufacturing setting.

You will work with Quality, Manufacturing and Engineering on sustaining activities, coordinating software requirements, validations and CAPA to meet regulatory standards. This role offers growth within a global healthcare leader and exposure to CFR21/FDA requirements.