QMS & SAP/PLM Specialist — Regulatory & CAPA Expert

Essity; Reynosa; In loco; MXN 350.000 - 520.000; Tempo pieno

Descrizione del lavoro

Essity seeks a Quality Systems Specialist to create and administer technical documentation in SAP/PLM for Reynosa products, coordinating with the USA legal manufacturer for approvals related to product changes.

You will act as QMS administrator for Reynosa & Hidalgo DC, support associates, oversee software validation, CAPA/deviations, and participate in audits while ensuring compliance with ISO 13485:2016, FDA 21 CFR Part 820, and NOM-241-SSA1-2021.

Competenze

• 2 years of experience in a related position 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.
• Experience and great interpersonal skills for daily in-person / virtual, email, and interaction with employees.
• Goal Oriented, Proactive, and Collaborative.
• Proven experience with establishing and prioritizing tasks and objectives to manage time and resources appropriately.

Mansioni

• SAP / PLM Administrator for technical documentation (products specification/JB2. Raw materials) for all manufactured products in Reynosa.
• Main contact between Legal Manufacturer in USA and Reynosa team related product changes process.
• GMS (Global Management System) Administrator for QMS documents - Reynosa & Hidalgo DC.
• Assists associates in understanding and maintaining the QMS for Reynosa & Hidalgo DC.
• Software validation administrator for all Reynosa processes.
• Internal Auditor (ISO 13485:2016, FDA (21 CFR Part 820) and NOM-241-SSA1-2021 requirements).
• CAPA/Deviation administration.
• Monitoring trends about QMS (and reporting).
• Training personnel on QMS.
• Participating in internal / external regulatory and customer audits.

Conoscenze

Quality Management Systems

Documentation skills

Communication skills

Time management

Collaboration

Strumenti

SAP

PLM

Microsoft Office

Database applications

Descrizione del lavoro

Essity seeks a Quality Systems Specialist to create and administer technical documentation in SAP/PLM for Reynosa products, coordinating with the USA legal manufacturer for approvals related to product changes.

You will act as QMS administrator for Reynosa & Hidalgo DC, support associates, oversee software validation, CAPA/deviations, and participate in audits while ensuring compliance with ISO 13485:2016, FDA 21 CFR Part 820, and NOM-241-SSA1-2021.