Software Quality Engineering - Queretaro Site

Abbott · Queretaro, Mexico

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Role summary

Abbott seeks a Software Quality Engineer for its new Electrophysiology manufacturing facility in Querétaro, Mexico. The role involves implementing GMP-compliant quality systems, validating non-product software, and ensuring regulatory adherence across manufacturing operations.

What they're looking for

3+ years experience with computer applications (MES, INFOR, Power BI, Excel)
1+ year quality-related position experience
1+ year project management experience
2+ years regulated industry experience (pharmaceutical, food, cosmetics)
2+ years Computer System Validation (CSV) project involvement
Intermediate to advanced English proficiency
SAP knowledge desirable

What you'll be doing

Implement Electrophysiology Software Quality Systems ensuring GMP compliance and business continuity
Support creation of software requirements, test plans, protocols, and validation reports for non-product software
Identify, standardize, and document software validations meeting current regulations and medical industry standards
Guide and develop other software quality engineers in non-product software lifecycle management
Coordinate with Quality, Manufacturing, IT, and Engineering teams on sustaining and project activities ensuring regulatory compliance

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Date posted6 days ago

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