Carolina Mendoza

- Member of the WAVE 1 Team for the creation and release of the Electronic Quality Management System on the Windchill platform (One PLM) for the Greenfield site (Stryker Tijuana Operations).

• Control, maintain and update all documents related to the quality system, including standard procedures, work instructions, quality manual, etc.
• Execution of the CAI and CAII Roles in One PLM.
• Create material bills (BOM), Material Master and Part Numbers in SAP generated with data provided by Engineering.
• Collaboration in internal and external audits (shadow, back room) - Submission of documentation to ensure alignment with the quality system and applicable regulatory requirements.
• Documentation obsoletiztion as necessary in accordance with applicable procedures.
• Provide support for the audit of ECR/ECNs/CTs/Promotions Requests.
• Organization and administration of Change Revision Boards (CRBs) - Organization and administration of the Change Implementation Design Task (CIDTs) process for Stryker Tijuana Operations and Stryker Tijuana Mexico.
• Provide training to administrative staff about Good Documentation Practices.
• Create and maintain a log of Documentation Control audits to control, prioritize and follow up on change requests.
• Owner and monitoring of NCs and CAPAs of the Documentation Control department.

STRYKER PROFESSIONAL RAQA–Greenfield Site-D ocument Control Coordinator | Jan 2021-Actual| Tijuana, B.C. Mexico

JABIL HEALTHCARE Manufacturing Engineering – Workcell Team PHILIPS- Manufacturing Engineering Change Coordinator I| Mayor 2020- January 2021| Tijuana, B.C. Mexico.

BAXTER HEALTHCARE Quality Department (Operations Quality Engineering Intern) | September 2019- March 2020 | Tijuana, B.C. Mexico.

Ingenieria Industrial