PRIMARY OBJECTIVES AND RESPONSIBILITIES Lead daily quality operations at the manufacturing site, including incoming, in-process, and final inspection, testing, and product release.
Oversee Quality Management System (QMS) processes such as change control (ECR/ECO), document management, records retention, training/competency, CAPA, NCMR, complaints, and calibration.
Supervise and develop Quality Engineers and Quality Assurance personnel, including performance management, coaching, and workforce planning.
Ensure compliance with FDA QMSR, ISO 13485, MDSAP, and Good Documentation Practices through effective procedures and controls.
Lead internal and external audits, including ISO/MDSAP audits and regulatory inspections, serving as the site's primary host.
Maintain and monitor quality metrics and KPIs, presenting monthly results and driving actions through Management Review and other Quality governance processes.
Lead investigations for quality trends and issues, implementing corrective and preventive actions to improve outcomes.
Support risk management processes and ensure integration into key quality activities, including complaints, nonconformances, and change control.




Bachelor’s degree in engineering, quality, or related scientific field (or equivalent experience).
Minimum 5 - 8 years of working experience in Quality within a regulated manufacturing environment, or advanced degree with 3 years of relevant experience.
3 plus years leading Quality Operations in a medical device manufacturing site along with Quality projects.
Strong knowledge and working experience with ISO 13485, MDSAP, FDA QMSR (21 CFR Part 820) requirements, and Good Documentation Practices.
Experience maintaining and improving an effective Quality Management System.
Experience managing quality assurance and regulatory compliance to drive audit and inspection readiness.
Experience guiding and coaching others.
Experience with FDA inspections and registrar/notified body audits
Willingness and ability to travel internationally up to 20% as needed.
Proficient in English language: Fluent level (Reading, writing and speaking)
Proficiency in Microsoft Office and ERP/QMS systems.

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📌 Quality Manager (Medical Processes Exp- Parq. Ind. El Bajio) (Tecate)
🏢 Mam De La Frontera, S. A. De C. V.
📍 Tecate