Quality Systems Specialist: SAP/PLM & QMS Admin

Essity Higiene y Salud México, S.A. de C.V; Reynosa; On-site; MXN 250,000 - 420,000; Full time

Job summary

Essity Higiene y Salud México, S.A. de C.V. in Reynosa is seeking a Quality Systems Specialist to manage QMS documentation, SAP/PLM data, and ensure compliance with ISO 13485 and FDA standards.

You will partner with the Legal Manufacturer in the USA on product changes, validate software, train staff, and support internal and external audits.

This role requires meticulous attention, strong communication, and hands-on experience with QMS processes to keep Reynosa operations compliant and efficient.

Qualifications

• Experience with ISO 13485:2016 and FDA 21 CFR Part 820.
• Ability to train personnel and maintain QMS documentation.
• Strong writing and communication skills.
• Experience with SAP/PLM for technical documentation.

Responsibilities

• SAP/PLM administrator for technical documentation (products and raw materials) in Reynosa.
• Main liaison between USA Legal Manufacturer and Reynosa team for product changes.
• GMS administrator for QMS documents for Reynosa & Hidalgo DC.
• Assists associates in understanding and maintaining the QMS.
• Software validation administrator for Reynosa processes.
• Internal Auditor for ISO 13485:2016, FDA 21 CFR Part 820 and NOM-241-SSA1-2021.
• CAPA/Deviation administration.
• Monitoring trends about QMS and reporting.
• Training personnel on QMS.
• Participating in internal/external regulatory and customer audits.

Skills

ISO 13485

FDA 21 CFR 820

QMS

CAPA

Auditing

Documentation

Communication

Tools

SAP/PLM

Microsoft Office

Databases

Job description

Essity Higiene y Salud México, S.A. de C.V. in Reynosa is seeking a Quality Systems Specialist to manage QMS documentation, SAP/PLM data, and ensure compliance with ISO 13485 and FDA standards.

You will partner with the Legal Manufacturer in the USA on product changes, validate software, train staff, and support internal and external audits.

This role requires meticulous attention, strong communication, and hands-on experience with QMS processes to keep Reynosa operations compliant and efficient.