Abbott
Healthcare
SoftwareQualityEngineering
Neural analysis suggests this role is
optimal for Senior candidates.
“Software Quality Engineering at Abbott. Skills: Software Quality Engineering, GMP compliance, Computer System Validation (CSV). Implement Electrophysiology Software Quality Systems. Ensure business/plant continuity”
What You'll Achieve.
Ensure business / plant continuity; Achievement of Key Performance Indicators
Industry & Context.
What They're Looking For.
Must Have
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 13485, Systems: MES, SAP, Power BI, MS Office
Nice to Have
Self-driven, results-oriented, cross-functional collaboration skills
What You'll Do.
Implement Electrophysiology Software Quality Systems
Ensure business/plant continuity
Design software requirements
Validate non product software
Support process validation activities
standardize and document software validations
leads and/or develops other software quality engineers
Apply software quality methodologies
Ensure non-product software adhere to regulations
approve and ensuring software requirements
Ensure compliance with CFR21
FDA and other applicable regulations
How You'll Work.
Team & Collaboration
Works closely with Quality, Manufacturing and Engineering; Works closely with Quality, Manufacturing, IT, Microbiology, Calibration, and Engineering
Process & Methodology
Project Management
Full Job Description
## **JOB DESCRIPTION:** **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** 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
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