Quality Systems Architect: QMS & SAP/PLM Lead

Essity; Reynosa; On-site; MXN 300,000 - 520,000; Full time

Job summary

Essity Reynosa is seeking a Quality Systems Specialist to manage technical documentation in SAP/PLM for all manufactured products. You will coordinate with the Legal Manufacturer in the USA, support QMS maintenance, and lead internal audits.

The role requires ISO 13485:2016, FDA 21 CFR Part 820, NOM-241-SSA1-2021 knowledge, strong writing skills, and teamwork to drive process improvements. On-site involvement includes daily collaboration with production and quality teams, training personnel, and

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.
• Goal Oriented, Proactive, and Collaborative.
• Proven experience with establishing and prioritizing tasks and objectives to manage time and resources appropriately.

Responsibilities

• Create and administer technical documentation in SAP/PLM for products and raw materials.
• Serve as main contact between USA Legal Manufacturer and Reynosa team for product changes.
• Administer GMS for QMS documents in Reynosa & Hidalgo DC.
• Assist associates in understanding and maintaining the QMS.
• Serve as software validation administrator for Reynosa processes.
• Act as Internal Auditor for ISO 13485:2016, FDA 21 CFR Part 820 and NOM-241-SSA1-2021.
• Manage CAPA/Deviations and monitor QMS trends.
• Train personnel on QMS and participate in audits.

Skills

ISO 13485 knowledge

FDA 21 CFR Part 820 knowledge

NOM-241-SSA1-2021 knowledge

Technical documentation

Excellent writing

Interpersonal skills

Proactive & collaborative

Tools

SAP

PLM

Microsoft Office

Job description

Essity Reynosa is seeking a Quality Systems Specialist to manage technical documentation in SAP/PLM for all manufactured products. You will coordinate with the Legal Manufacturer in the USA, support QMS maintenance, and lead internal audits.

The role requires ISO 13485:2016, FDA 21 CFR Part 820, NOM-241-SSA1-2021 knowledge, strong writing skills, and teamwork to drive process improvements. On-site involvement includes daily collaboration with production and quality teams, training personnel, and