Highlights:

Skills:Regulatory Audits, Project Management, Critical Thinking, Process Improvements, Team Leadership, Team Leadership, Statistical Analysis, Risk Management, Test Methodologies, Design Control, Product & Process Validation

Goal:Dedicated Engineer with comprehensive systems administration, and quality assurance auditing expertise. Skilled at leading and inspiring cross-functional teams to deliver successful projects. Experience working with geographically diverse cross-functional teams of management, engineers, and highly regulated industries. Confident Principal Engineer with the ability to balance multiple tasks while ensuring quality. Fluent in Spanish, English, and Portuguese.

Certification:ASQ Certifications: - Certified Manager of Quality /Organizational Excellence (CMQ/OE) - Certified Quality Auditor (CQA) - Certified Quality Engineer (CQE) BSI Lead Auditor Certification ISO 13485:2016 (MDv 2.0, TLv2.0 and AUv 2.0).

Sr. Quality Systems Engineer Sep/2022 - Sep/2023
Becton Dickinson, Vernon Hills IL, United States
Industry: Medical Devices
Oversaw activities in Research and Development (R&D) and Manufacturing facilities to execute Internal Audits as well as host corporate, external, regulatory agencies and FDA inspections and inspections and provided support to prepare and complete responses in a timely manner.
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Sr. Quality Assurance Engineer -Design Transfer Jan/2021 - Sep/2022
Becton Dickinson, El Paso, TX United States
Industry: Medical Devices
Collaborate with Product Engineering and R&D with the design and execution of new products Process Validations activities: URS, SAT, FAT, DQ, IQ, PQ, OQ and PPQ. Managed Design transfer Team, Technicians and Associate Engineers.
• Aligned with Research and Development to ensure new product transfers were current on product features and intended use after being integrated into Mfg. plant requirements. • Partnered with Regulatory Affairs to prepare Technical Documentation Submission and the Design Transfer Engineering team to create processes and procedures for Product Reviews (XRs) and attain successfully new project launches. • Created test method validations for Raw materials, artwork process, and finished good product inspections, utilizing precision measurement equipment and ASTM principles. • Generated and implemented procedures for new transfer product inspection activities. • Collaborated during the Process Review Stage to support the creation and approval of transfer phase requirements: Sterilization and Distribution, process requirements specifications, Design Transfer plans, etc. • Optimized inspection plans across In-process Inspections for Packaging areas to improve inspection effectiveness and process performance predictability (Variable sampling, K-Method). • Designed and implemented Raw Materials Component Qualification process based on product (DFMEA-PFMEA) risk outcome. • Participated in Design Reviews and provide input to develop Design Matrix and DFMEAs.--
Quality Assurance Engineer Dec/2017 - Jan/2021
Becton Dickinson, El Paso, TX United States
Industry: Medical Devices
Monitored all quality assurance functions (In-process QA inspections, release, NCRs, and retained samples). Supervised QA technicians Team.
• Participated in Automation Optimization Projects to increase automated assembly process output in a 5%. • Elaborated and conducted Equipment Validation plans (IQ and Software Validation) for product quality inspections: Drug container Integrity Testing System, product packaging: seal strength, seal width, thickness , tear notch location and package integrity. • Lead and implement Corrective and Preventive actions to reduce 15% Customer Complaints related to Foreign Matter. • Implemented improvements on Non-conformances process and procedure, to reduce in an 80% late NCR closure related to Bioburden and raw material. • Designed and implemented QA Technicians Training certification process to provide flexibility in the QA Techs functions. • Conducted Customer Complaints Investigation and Corrective actions and maintained customer complaints closure goal of 30 days. • Lead cost reduction project to reduce in a 50% monthly expenses on Lab. coats required at CME Manufacturing area.--
Quality Systems Manager Nov/2017 - Nov/2016
Bard, Juarez, Chihuahua Mexico
Industry: Medical Devices
Coordinated Quality systems department: Quality Audits Lead and Document Control Department (Change management process, record retention, and CoC generation).
• Controlled labeling projects: UDI Integration, and validation for new labeling printing Software (EnLabel). • Spearheaded the initiative to implement real-time data collection across SPC Processes on Bard Juarez by integrating the use of Interfaces of measurement instruments. • Aligned with the management team to standardize Company KPIs reports for Corporate Metrics. • Oversaw CAPA coordinator activities.--
Quality Systems Manager Nov/2016 - Nov/2017
Flex, Juarez, Chihuahua Mexico
Industry: Medical Devices
Directed Quality systems department, internal audits program and Internal auditor’s certification process.
• Hosted and coordinated audits for Customers, FDA readiness plan, and Corporate and followed up on responses required post-audit. • Oversaw transition activities to migrate QMS to the latest revision ISO 13485:2016. Supervised Certification audit to ISO 13485:2016. • Executed and assisted in gap assessment remediation activities required for Quality Management System compliance to 21 CFR Part 820. • Streamlined the Document Control Department (Change management process, record retention, and DHR review/certification).--
CAPA Coordinator Sep/2011 - Nov/2013
Bard, Juarez, Chihuahua Mexico
Industry: Medical Devices
Coordinate CAPA System activities
• Standardized and deployed the use of Investigation techniques (C&E Analysis, 5whys, Is -is not) for the CAPA system, unified investigation forms for CAPA, Internal Rejects and External Rejects (Intercompany/customer) and collaborated in the implementation of project HER (Human Error Reduction). • Developed standard operational procedures to implement SPC projects and maintain standardization among existing and new projects. • Implemented the use of Risk Management tools to have an efficient Investigation system (Escalation process based on risk), across CAPA systems, SCAR, Internal Rejects, External Rejects (Intercompany). • Collaborated with corporate team to Implement Software (Master Control) for the administration of CAPA process.--
Quality Assurance Engineer Aug/2010 - Sep/2011
Bard, Juarez, Chihuahua United States
Industry: Medical Devices
Monitored all quality assurance functions (In-process QA inspections, release, NCRs, and retained samples). Supervised QA technicians Team.
• Implemented Software InfinityQS SPC projects on Manufacturing process (Sealing, Welding and Bonding process) to eliminate the use of manual SPC sheets and optimize inspection report GdP. • Supported, reviewed and approved engineering Validation activities (Software, SAT, FAT, IQ, PQ, OQ) for multiple process : Packaging, Welding (Ultrasonic, RF), Assembly, pouch mfg. , solution filling , automation and Validations for SIB (Stay in Business projects): Packaging and Plastic components. • Leaded and coordinated critical CAPA Investigations: Eliminate packaging integrity defects in a 100%, Reduce to zero mixes on Labeling process to achieve effective CAPA implementation.--

Universidad Autonoma de Cd. Juarez Aug/2005 - Aug/2010
Juarez, Chihuahua, Mexico
Degree: Bachelor's Degree
Major:Systems
Industrial Engineer graduate with minor in Systems

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