August 2023 – Current
Senior Quality Engineer
Productos Medline S.A. de C.V | Nuevo Laredo, Tamaulipas
- Monitored environmental conditions in warehouse and clean rooms, including temperature control room
- Developed and defined measurement equipment and test methods for evaluating component or process inspections
- Defined and directed projects to enhance quality standards while reducing expenses
- Act as Lead Internal Auditor for ISO-13485 compliance
- Managed the implementation of Corrective and Preventive Actions to address customer complaints and process non-conformities
- Participated in the implementation of Viable and Endotoxin LAL testing for medical devices
April 2022 - August 2023
Supplier Quality Engineer
Productos Medline S.A. de C.V. | Nuevo Laredo, Tamaulipas
- Managed the review and validation process for sourcing paperwork to ensure compliance with company standards.
- Verified the accuracy of FDA and regulatory information
- Ensured accurate coding of medical devices by implementing QW and CH codes based on component characteristics and vendor provided data.
- Conduct periodic internal audits
- Managed the retrieval of rejected finished goods designated for sterilization
- Managed the processing and approval of ECN's related to changes in medical components
- Directing improvement projects in the warehouse by creating and managing strategies
- Oversaw the sourcing of medical components to ensure adherence to regulations, accurate documentation, and final approval before they used in production.
- Ensured seamless communication and coordination between quality, production, and sterilization teams for the prompt return of finished goods requiring rework.
September 2016 - April 2022
Sourcing Technician
Productos Medline S.A. de C.V. | Nuevo Laredo, Tamaulipas
- Ensured accuracy in FDA coding by thoroughly verifying and rectifying discrepancies
- Facilitated the smooth transition of COO, EXP, and QWS changes via efficient processing of ECNs
- Ensured smooth workflow of OCN photo modification process on updating images in the company’s database
- Verified the accuracy of manufacturing and regulatory details while appropriately assigning Quality Warning and Component Handling codes.
- Coded medical components and finished goods with accurate FDA information, ensuring compliance
October 2015 - September 2016
Quality Control Inspector
Productos Medline S.A. de C.V. | Nuevo Laredo, Tamaulipas
- Conducting inspections on medical kits to identify damaged components, particulates, incorrect assembly, and nonconformance
- Verified and closed DHR after ensuring accuracy of work order details, such as product, lot number, country of origin, expiration dates, deviations, customer change requirements, line clearances, and QC inspection.
- Demonstrated commitment to meticulous inspection, verifying kit integrity, maintaining accurate records, and delivering exceptional quality service to minimize the likelihood of customer or client complaints.
July 2015 - October 2015
Production Operator
Productos Medline S.A. de C.V. | Nuevo Laredo, Tamaulipas
