JOB DESCRIPTION:
We are hiring
Software Quality
Engineer
About Abbott
Abbott, general 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
Work in the implementation of Electrophysiology Software Quality Systems, ensuring the business / plant continuity through Good Manufacturing 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
Design 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 escalate 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
Bachelor's/Engineering degree (completed)
+5 years in in the same rol
Advanced English (mandatory)
Experience in regulated industries (medical devices/pharma)
Computer System Validation (CSV)
+3 years Project Management
Knowledge of FDA, GMP, ISO *****
Systems: MES, SAP, Power BI, MS Office
Self-driven, results-oriented
Strong cross-functional collaboration skills
Follow your career aspirations to Abbott for diverse opportunities with a company that can help you build your future and live your best life. Abbott is an Equal Opportunity Employer, committed to employee diversity.
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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

📌 Software Quality Engineering - Queretaro Site (México)
🏢 Abbott
📍 México