Job SummaryWe are building a manufacturing facility in Querétaro, Mexico, as part of Abbott's Electrophysiology (EP) business.This role focuses on implementing and maintaining the quality system across the facility in compliance with Mexican regulations, FDA QSR, ISO *****, and company policies.Key ResponsibilitiesProvide Quality System Body of Knowledge support to the organization.Lead cross‐functional teams to execute Quality System initiatives.Participate in or lead teams supporting quality disciplines, decisions, and practices.Draft, review, and update Quality Systems documentation for compliance.Support and execute internal/external Quality System audits.Ensure compliance to all Quality System regulations and policies; perform gap analysis and implement improvements.Identify opportunities for improvement in compliance.Support and resolve investigations related to non‐conformances or improvement opportunities.Assist new product introductions, ensuring quality deliverables, Quality Plans and Risk Management.Translate regulations into user‐friendly SOPs and Work Instructions.Support CAPA system elements for the site.Maintain positive communication and collaboration with all stakeholders.May be responsible for specific areas within the quality systems organization, leading personnel management, training, and development.Perform other duties as assigned.Support divisional initiatives across Quality Management Systems (QMS), Environmental Management Systems (EMS),



and other regulatory requirements.Handle change request administration and ERP configuration control.Maintain documentation databases and enforce adherence to written documentation policies and procedures.QualificationsRequiredEngineering, Business Administration, or Science degree.4–6 years of experience in quality positions.Advanced command of English.Minimum 2 years' experience in FDA QSR, ISO ***** or ISO **** controlled industry.Demonstrated knowledge of quality systems—including training, documentation, testing and/or quality release.Experience in quality, engineering or structured processes, preferably in medical devices.Exposure to regulations for medical devices (FDA QSR, ISO *****).
Knowledge of process improvement (Root Cause Analysis, Fishbone, Six Sigma, SPC).
Proficiency in MS Excel, Word, PowerPoint.PreferredQuality Auditor training for ISO ***** Lead Auditor or ISO **** certified Quality Engineer or AAMI Quality Systems.Certifications in Quality Control, CAPA, Risk Management.Quality Management, Operational Excellence, Project Management certifications.1–2 years of experience participating in ISO and/or FDA audits.LocationQueretaro, Mexico – Avenida FINSA 156, Lote 12.Job FamilyOperations Quality – EP Electrophysiology.Employment DetailsWork shift: Standard.Travel: Not specified.Medical Surveillance: Not Applicable.EEO StatementAbbott is an Equal Opportunity Employer, committed to employee diversity.
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📌 Quality Systems Engineer - Queretaro Site (Santiago de Querétaro)
🏢 Abbott Laboratories
📍 Santiago de Querétaro