*quality systems specialist*
*about the role*
the management 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.
Is responsible to create, update and administrate the qms documentation (sops, wi’s, forms) in gms (global management system) platform for reynosa & hidalgo dc.
Responsible to coordinate and administrate the software validations for all reynosa processes.
Perform internal audits and assists during external and global audits.
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.
*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*
- bachelor’s degree in engineering field preferred.
- 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.
- bilingual english/ spanish.
- 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. Working at essity means a chance to improve well-being for people and opportunities to drive positive change for the society and the environment. As an employee at essity, you will belong to an organization where you feel valued and supported to grow, and challenged to generate business results in a collaborative and open atmosphere. Innovate for good | excel together | be you with us
reynosa villa florida
*application end date*:
09 feb 2025
*job requisition id*:essity250292