Rafael Vazquez Morua

Results oriented Industrial and Sy stems Engineer with a strong work ethic, adaptability and a passion for problem solving. Adept at working effectively unsupervised and quickly mastering new skills. Seeking new employment opportunities to further develop professional skills and contribute to company success.

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

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

2016 - 2019

Industrial and Systems Engineering

Universidad Tecmilenio

Monterrey, Nuevo León México