QMS & SAP/PLM Administrator - ISO Auditor Ready

Essity; Reynosa; On-site; MXN 420,000 - 540,000; Full time

Job summary

Essity in Reynosa, Mexico seeks a Quality Systems Specialist to create and administer technical documentation in SAP/PLM for all manufactured products. You will coordinate with the Legal Manufacturer in the USA for approvals related to product changes and act as GMS administrator for QMS documents across Reynosa and Hidalgo DC.

You will also validate software processes, perform internal audits to ISO 13485:2016 and FDA 21 CFR Part 820, manage CAPA/deviation, train personnel, and support

Qualifications

• 2 years of experience in 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.

Responsibilities

• 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.

Skills

ISO 13485

FDA CFR 820

NOM-241-SSA1

SAP/PLM

QMS administration

Auditing

CAPA management

Training

MS Office

Database platforms

Tools

Microsoft Office

Database platforms

Job description

Essity in Reynosa, Mexico seeks a Quality Systems Specialist to create and administer technical documentation in SAP/PLM for all manufactured products. You will coordinate with the Legal Manufacturer in the USA for approvals related to product changes and act as GMS administrator for QMS documents across Reynosa and Hidalgo DC.

You will also validate software processes, perform internal audits to ISO 13485:2016 and FDA 21 CFR Part 820, manage CAPA/deviation, train personnel, and support