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Belen Lopez
14620 Sunny Land Avenue | El Paso, TX 79938 Mobile: (915) 539-7653 | Email: [email protected]
Profile Summary
Energetic, result-oriented professional offering Customer Complaint Management complementing
administrative, office management and customer service background. Characterized with passion,
dedication and social maturity that resolves concerns and influences agreement. Noted for ability to
relate to clients and patients, explain technical terms and needs into digestible, simple and
understandable language. Proficient at establishing and maintaining multifaceted management,
metrics, filing and recordkeeping systems.
Customer Relations ▪ Compliance ▪ Administration ▪ Productivity Optimization ▪ Quality Assurance
Professional Experience
CareFusion, El Paso, TX April 09, 2013 – November 07, 2014
CUSTOMER ADVOCACY ANALYST: Interacted directly with customers, as well as staff positions, including traveling to sites as needed, in
order to appropriately assess customer experience. Field Alert Reporting (FAR) and Medical Device Reporting (MDR) determination and tracking,
maintenance of spreadsheet. Responsible for addressing FDA inquiries and completing post-surveillance studies, as required.
Identifying/recommending new product account implementation support ideas and works in conjunction with implementation teams.
Reviewed medical/scientific literature to maintain expertise and current awareness of relevant issues to products.
Responsible for following and practicing FDA GMP, ISO, MHRA, CFR 820 and CFR 821 compliance regulations which includes assisting with internal and external audits.
CareFusion, El Paso, TX August 2012 - April 8, 2013 SENIOR CUSTOMER ADVOCACY SPECIALIST: Responsible for managing the complaint related customer experiences for our products and services,
as well as initiating product investigations, and identifying root causes and corrective actions, inspections, initiating containment actions when required, prioritizing business opportunities and product and service solutions.
Alerting management to trending critical safety issues, raising awareness and concerns related to mechanical failures or possible health hazards.
Responsible for leading team personnel and projects that includes mentoring, training new members and delegating tasks to team members.
FAR reporting determination and tracking, maintenance of spreadsheet. Coordinated with risk assessments that include the evaluation of potential patient safety risks and
field actions. Monitoring and maintenance of the logbooks, meeting, and trends.
CareFusion, El Paso, TX September 2010 – August 2012QUALITY COORDINATOR (CUSTOMER COMPLAINTS):
Belen Lopez Mobile: (915) 539-7653 | Email: [email protected]
Complaint investigations and remediation leader. Complaint system leader for new software development (validation, implementation and continuous
improvements). Created new Global work flows for the new countries and regulations (SmartComplaints). Participated as the quality party in the MRB meetings for rejected material disposition. Evaluated material returns associated with customer complaints identified root cause and corrective
actions, lead or facilitate remediation and provide feedback to customers. Coordinated investigations and communicating with different department such as manufacturing,
engineering, quality, customer service and regulatory affairs. Tracking and reporting program experience analyze data and develop recommendations for program
compliance or improvements.
CareFusion, El Paso, TX September 2010 - August 2011
QUALITY COORDINATOR (TRAINING):
Responsible for all training functions for all departments, that includes training on ISO and GMP. Maintained training records for all employees and ensuring that was performed on existing
procedures and specifications. Tracked each employees training was by performing audits on auditing daily, weekly and monthly
basis. Developed and maintained training metrics.
Cardinal Health, El Paso, TX May 2008 - September 2010
QUALITY COORIDNATOR: Responsible for assuring that the production floor was covered with the sufficient Quality support to
perform inspection, and release product in a timely manner. Assisted in validations and engineering test, with engineering and maintenance assuring that all
procedures are being followed. Completion of changes on procedures and documents that affect the quality system and assure the
proper training has been conducted to all affected parties. Responsible for following and practicing FDA GMP, ISO, MHRA, CFR 820 and CFR 821 compliance
program.
Enturia / Medi-Flex, El Paso, TX January 2000 - May
2008
PRODUCTION COORDINATOR/QUALITY TECH/PRODUCTION OPERATOR: Production Coordinator
o Responsible for setting up the manufacturing settings and the positioning and instruction of the manpower to run the equipment.
o Responsible for following and practicing FDA GMP/ISO compliance program.o Providing training to associates in the operation of equipment, processes and procedures. o Monitored and tracked of production efficiencies, quality of the product, housekeeping, scrap,
and material usage. o Completing documentation, batch records, production records, and housekeeping records.
Quality Technician
Belen Lopez Mobile: (915) 539-7653 | Email: [email protected]
o Calibration of all equipment used in the production and receiving areas. Collected data for validations and engineering tests.
o Completed non-conformance notices and quality alerts when required.o Developed and maintaining quality metrics.
Production Operatoro Responsible for performing the operations related to each particular area or work station as
established in the pertinent operation’s standard operating procedures.o Responsibilities also included promoting a safe work environment.
EducationMaster Degree in Business Administration (05/2014)
University of Phoenix, El Paso TX
Bachelor of Science in Business Management (04/2011)
University of Phoenix, El Paso TX
Basic Academic Courses (01/2001 – May 2002)
El Paso Community College, El Paso TX
High School Diploma Completion (12/1999)
Del Valle High School, El Paso TX
Trainings
Validations Training Part I (03/2014) – Agalloco & Associates and DeSantis Consulting AssociatesExcel (2011)
Technical Skills
Microsoft Applications such as Word, Excel, Office, Outlook, PowerPoint and Windows. SmartComplaint System Pilgrim Software, EtQ (CAPA System), Oracle, Internet, and Bilingual literate (Spanish).
