Abbott

Healthcare

SoftwareQualityEngineering

Queretaro, Mexico FULL TIME
Market Sentiment
HIGH DEMAND

Neural analysis suggests this role is
optimal for Senior candidates.

The Brief

“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.

Healthcare

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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