Quality Systems Specialist — SAP/PLM & QMS Champion

Essity Higiene y Salud México, S.A. de C.V; Reynosa; Híbrido; MXN 360.000 - 480.000; Jornada completa

Descripción de la vacante

Essity Higiene y Salud México, S.A. de C.V.

Reynosa site is seeking a Quality Systems Specialist to create and manage technical documentation in SAP/PLM for all manufactured products, coordinating approvals with the USA Legal Manufacturer and maintaining QMS documents across Reynosa and Hidalgo DC. You will train staff, support software validation, and participate in ISO/FDA/NOM-241-SSA1-2021 audits while monitoring QMS trends and CAPA/Deviations.

Formación

• 2 years of experience in a related role or similar.
• Strong knowledge of ISO 13485:2016, FDA 21 CFR Part 820 and NOM-241-SSA1-2021 requirements.
• Excellent writing and communications skills.
• Experience in Microsoft Office and database applications/platforms.
• Great interpersonal skills for daily in-person/virtual, email interactions with employees.
• Goal oriented, proactive and collaborative.
• Proven ability to establish and prioritize tasks to manage time and resources.

Responsabilidades

• SAP/PLM Administrator for technical documentation for all Reynosa products.
• Main contact between USA Legal Manufacturer and Reynosa team for product changes.
• GMS Administrator for QMS documents (Reynosa & Hidalgo DC).
• Assist associates in understanding and maintaining the QMS for Reynosa & Hidalgo DC.
• Software validation administrator for all Reynosa processes.
• Internal Auditor for ISO 13485:2016, FDA 21 CFR Part 820 and NOM-241-SSA1-2021.
• CAPA/Deviation administration and trend monitoring of QMS.
• Train personnel on QMS and participate in audits.
• Support internal/external regulatory and customer audits.

Conocimientos

Writing skills

Communication

MS Office

Interpersonal skills

Time management

Collaboration

QA knowledge

Herramientas

SAP/PLM

QMS software

Descripción del empleo

Essity Higiene y Salud México, S.A. de C.V.

Reynosa site is seeking a Quality Systems Specialist to create and manage technical documentation in SAP/PLM for all manufactured products, coordinating approvals with the USA Legal Manufacturer and maintaining QMS documents across Reynosa and Hidalgo DC. You will train staff, support software validation, and participate in ISO/FDA/NOM-241-SSA1-2021 audits while monitoring QMS trends and CAPA/Deviations.