Quality Systems Specialist

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

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