The quality systems specialist is responsible for creating and administrating technical documentation (product and raw materials specifications, prints) in the sap / plm platform for all manufactured products in reynosa pc. This role interacts with the legal manufacturer in the usa to require or send approvals related to product changes.
responsibilities include creating, updating, and administrating the qms documentation (sops, wi’s, forms) in the gms (global management system) platform for reynosa & hidalgo dc. The specialist will coordinate and administrate software validations for all reynosa processes, perform internal audits, and assist during external and global audits.
what you will do
1. sap / plm administrator for technical documentation (products specification/jb2, raw materials) for all manufactured products in reynosa.
2. main contact between the legal manufacturer in the usa and the reynosa team related to product changes process.
3. gms (global management system) administrator for qms documents for reynosa & hidalgo dc.
4. assist associates in understanding and maintaining the qms for reynosa & hidalgo dc.
5. software validation administrator for all reynosa processes.
6. internal auditor (iso 13485:2016, fda (21 cfr part 820), and nom-241-ssa1-2021 requirements).
7. capa/deviation administration.
8. monitor trends about qms and reporting.
9. train personnel on qms.
10. participate in internal/external regulatory and customer audits.
who you are
1. 2 years of experience in a related position or similar.
2. strong knowledge of iso 13485:2016, fda (21 cfr part 820), and nom-241-ssa1-2021 requirements.
3. excellent writing and communication skills.
4. experience in microsoft office and database applications/platforms.
5. great interpersonal skills for daily in-person/virtual, email, and interaction with employees.
6. goal-oriented, proactive, and collaborative.
7. 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 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
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