Tania Alejandra López Muñoz

• Joined forces closely with business partners to develop and maintain new Stratafix TM products, materials, and processes using a range of quality engineering tools.
• Provided technical expertise during audits to guarantee compliance with current good manufacturing practices and adherence to ISO 14971, ISO 13485, FDA, OSHA, MDD, 21 CFR 820, and domestic and international quality system directives.
• Offered guidance to project teams, suppliers, and other departments to align with company policies, procedures, and medical device regulations.
• Supported combination products, tracked and trended cleaning monitoring, and calculated yield to improve overall product quality.
• Excelled in implementing the global project for a new ERP system as a quality SME, consolidating seven existing JDE systems into a cloud-based SAP S/4 HANA system, and utilizing JIRA software for project tracking and release.
• Revised PFMEAs for various processes at Ethicon San Angelo to ensure continuous improvement and risk mitigation.
• Headed a CAPA to address critical tooling issues impacting multiple processes within the facility.
• Collaborated with corporate and sister plants in Europe and Mexico to successfully follow through on projects targeting high-runner products, aligning with volume goals, implementing the use of needle supply by another sister plant, and supplier change of the API.
• Offered training and guidance to on-site and offshore team members on quality assurance standards, policies, and procedures.
• Participated in the MDR project for Vicryl suture family products, working closely on writing validation documents and endorsing the escalation of a barcode issue identified during the validation that resulted in a global scope CAPA.
• Demonstrated competent performance and expertise in the validation process (IQ, OQ, and PQ) by actively participating in writing and executing validation protocols and creating sampling plans as required.

• Calibrated instruments and scales in the production area and quality lab
• Inspected inbound and outbound products for compliance with established industrial standards, company policies, and procedures
• Rejected defective products and approved correct products
• Managed and archived quality documentation and participated in internal and external quality audits
• Excelled in Kosher monthly audits, achieving zero observations under my supervision
• Mentored and encouraged employees to strive for excellence and foster professional growth
• Create quality system control standards, methods, and procedures to ensure compliance requirements were met
• Followed quality standards and procedures to minimize errors and maximize customer satisfaction
• Expertly sorted products and furnished expertise on non-conforming product requirements
• Increased customer satisfaction from 60% to 95% through adherence to quality standards and customer requirements (e.g. Chick-fil-A, McDonald's, etc.)
• Directed customer complaint quality-assurance projects and significantly reduced empty wrapper complaints by 90%

• Conducted validation studies for new product introductions
• Coordinated the release of quarantine products across multiple teams in Juarez, Covington, Reynosa, and Nogales
• Facilitated product transfer and training for guidewire family products from Glens Falls, NY, acting as the Quality Assurance Engineer Subject Matter Expert (SME)
• Served as a liaison between the division, BD Juarez, and the supplier for a resin change project valued at over $245 million
• Supplied support for validations (IQ, OQ, and PQ), process verification, and reviewed all documentation after changes
• Assured compliance with CSV validation for computerized systems and equipment used in manufacturing, testing, and storage of GxP data
• Developed and validated test methods for various projects
• Backed control plan and PFMEA for each validation project
• Proposed and carried out development and testing improvements to enhance usability, function, and performance
• Cooperated with quality control staff to complete inspections
• Strengthened risk management measures through increased spot-checking and randomization of inspections
• Collected data on integration issues and vulnerabilities and provided improvement recommendations
• Trained and guided both onsite and offshore team members in quality assurance standards, policies, and procedures
• Implemented continuous process improvement initiatives and suggested preventive and corrective actions to enhance operational efficiency
• Provided supervision and oversight to a team of 28 QC members to ensure compliance with ISO 13485:2016 standards
• Used the Master Control platform for effective change control of procedures.

• Closed a project involving over 3,000 customer complaints while directing a team of 16 customer complaint technicians
• Reviewed and approved investigation and response to customer complaints for BOC Juarez, Rochester, and Nogales products
• Received and evaluated product samples at BOC Juarez
• Plied daily follow-up on complaints assigned to BOC Juarez
• Successfully executed Backlog-Steady-state complaints project
• Employed FDA device codes to guarantee regulatory compliance
• Utilized Trackwise technology to document and track customer complaints
• Contributed to quality scorecard metrics
• Oversaw requisitions for the quality department
• Supervised personnel in charge
• Acted as a liaison between Field Assurance and investigators
• Conducted training for new employees
• Applied standardized investigation level II (MDR) for customer complaints
• Rendered valuable information for opening, developing, and closing CAPAs
• Gathered data on integration issues and vulnerabilities and formulated improvement recommendations