Software Quality Engineering - Queretaro Site

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

JOB DESCRIPTION:

MAIN PURPOSE OF ROLE

Summarize the main purpose of the role

MAIN RESPONSIBILITIES

We are hiring Software Quality Engineer

About Abbott

Abbott, global leading healthcare company, is investing in Mexico. We are building a manufacturing facility in Querétaro.

In Abbott's Electrophysiology (EP) business, we're advancing the treatment of heart disease through breakthrough medical technologies in atrial fibrillation, allowing people to restore their health and get on with their lives.

This facility will offer 1,200 local new jobs and will be the first health manufacturing facility in Querétaro (pioneers for healthcare Hub).

Working at Abbott

At Abbott, you can do work that matters, grow, and learn, care for yourself and family, be your true self and live a full life. You will have access to:

• Career development with an international company where you can grow the career you dream of.
• A company recognized as a great place to work in dozens of countries around the world and named one of the most admired companies in the world by Fortune.
• A company that is recognized as one of the best big companies to work for as well as a best place to work for diversity, working mothers, female executives, and scientists.

The Opportunity

Software Quality Engineer role purpose is work in the implementation of Electrophysiology Software Qnufacturing Practices (GMP) compliance of documental system, non-conformities, Corrective Action Preventive Action (CAPA), Complaints, Self-Inspections /Audits, Risks systems, among others Quality systems. Works closely with Quality, Manufacturing and Engineering on sustaining and projects activities to ensure compliance with the quality system requirements and achievement of Key Performance Indicators (i.e. NCMR's, projects, etc.).

What You'll Do

• 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 escalated 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

Qualifications

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.

Abbott is an Equal Opportunity Employer, committed to employee diversity.

The base pay for this position is N/A In specific locations, the pay range may vary from the range posted.

JOB FAMILY: Operations Quality

DIVISION: EP Electrophysiology

LOCATION: Mexico > Queretaro : Avenida FINSA 156, Lote 12

ADDITIONAL LOCATIONS:

WORK SHIFT: Turno 1 Day Shift (Mexico)

TRAVEL: Not specified

MEDICAL SURVEILLANCE: Not Applicable

SIGNIFICANT WORK ACTIVITIES: Not Applicable