Quality Systems Specialist

Essity Higiene y Salud México, S.A. de C.V; Reynosa; Hybrid; MXN 360,000 - 480,000; Full time

Job summary

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.

Qualifications

• 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.

Responsibilities

• 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.

Skills

Writing skills

Communication

MS Office

Interpersonal skills

Time management

Collaboration

QA knowledge

Tools

SAP/PLM

QMS software

Job description

Ensure that the processes within the QMS comply with internal and external requirements, are continually improved based on data and that deviations are properly investigated, and appropriate corrective actions are implemented.

We're looking for people who embody our values, aren't afraid to challenge, innovate, experiment, and move at a fast pace. We're always looking for ways to improve our products and ourselves. If this is you, we'd love to talk.

About the Role

The Quality Systems Specialist is responsible to create and administrate in SAP /PLM platform the technical documentation (Product and Raw materials Specifications, Prints) for all manufactured products in Reynosa PC, interacts with Legal Manufacturer in USA to require or send approvals related product changes.

What You Will Do

• 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.

Who You Are

• 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.

What We Can Offer You

Our purpose, Breaking Barriers to Well-Being, provides meaning to everything we do. Join us to improve well-being for people and drive positive change for society and the environment. At Essity, you'll feel valued, empowered to grow, and challenged to achieve business results in a collaborative and open atmosphere. Innovate for Good | Excel Together | Be You with Us