Carlos Lopez Urista
El Paso
Summary
Demonstrated managerial experience in quality and manufacturing improvement systems. Successfully coordinated FDA, ISO13485, and MDSAP audits for multiple facilities, achieving zero non-conformances. Seeking a Senior Quality Regulatory Affairs Management role to leverage expertise in implementing quality initiatives aligned with organizational goals.
Overview
38
38
years of professional experience
Work History
Quality and Regulatory Affairs Mgr.
Cardinal Health
Juarez & El Paso
09.2014 - 06.2026
- Presource division is making Custom Convenience kits for different types of surgeries
- Responsible for the Quality Department in Juarez and El Paso manufacturing facilities, with a QA headcount of 225 for a total headcount of 2500 employees
- Assure that Quality and Production process procedures, records and facilities are complying with FDA, CMDR, ISO 13485 and MDSAP, State requirements, corporate procedures and internal procedures
- Coordinate and plan FDA, BSI, Customer and Internal audits for both facilities.
- Handled customer complaints related to plant controllable and design issues.
- Monitoring CAPA projects for both facilities
- Supplier Monitoring performance for incoming raw materials, SCAR's and coordinate quality meetings
- Effective coordination of product transfer from other facilities to our facilities
Quality and Regulatory Affairs Manager
Cardinal Health
El Paso
10.2008 - 08.2014
- Ensured continuity of operations by providing assistance to Director of Quality and Regulatory Affairs.
- Provides technical and managerial guidance and direction to El Paso, Mexico, Dominican Republic and China processors
- Assure that Quality and Production process procedures, records and facilities are in compliance to FDA, CMDR, ISO13485 and EC Medical Device Directive, State requirements, corporate procedures and internal procedures
- Manage the Customer Complaint Management System for all Convertors facilities: El Paso, Mexico, Dominican Republic and China
- Manage the Raw Material Quality Assurance department which gives disposition to all facilities
- Coordinate and plan FDA, BSI, Customer and Internal audits for El Paso facility. To date I have coordinated and participated in 4 FDA audits, at least 10 BSI audits and numerous customer audits
- Develop, publish and manage the achievement of Quality Initiatives such as DPM's, CPM's and PQRs in China, Mexico and DR facilities
- Coordinated product transfers to China and other Convertors facilities to ensure timely delivery.
- Active participation with Marketing and Tech Services in the implementation of new products
- Coordination of the Customer Value Task Force to address customer concerns through the support of cross-functional areas: Marketing, Sales, Clinicians, R&D, Quality, Tech Services, Engineering and manufacturing Operations
Group Quality Manager
Cardinal Health
Chihuahua
06.2005 - 10.2008
- Responsible for providing Management, technical guidance and direction to Quality Management functions in Mexico and the Dominican Republic (Mexico - 4 facilities: Chihuahua, Delicias, Juarez and Cuauhtémoc and DR - Santo Domingo)
- Assured compliance with FDA, ISO 13485 and CE MARK regulatory requirements, corporate and internal procedures in Mexico and DR facilities
- Managed and achieved Quality Initiatives such as DPM's, CPM's, Cost and Service in Mexico and DR facilities
- Coordinate timely investigations of customer complaints to resolve quality problems using the 8D's problem solving techniques
- Effectively coordination of the products transfers to China
- Total involvement in Lean Six Sigma as Sponsor. Some Quality personnel involved as BB, GB and Kaizen leaders.
- Assure recertification of ISO13485 with TUV as Notified Body every year in Mexican facilities
- Responsible for coordinating the standardization for Best Practice in all facilities
- Active participation with Marketing and Tech Services in the implementation of new products
- (transferred to ELP in 2006)
Quality Manager
Cardinal Health
Chihuahua
01.1997 - 06.2005
- Managed two facilities with total of 940 employees located in Chihuahua with a quality headcount of 45 people
- Assured compliance with FDA, ISO 13485 and CE MARK regulatory requirements
- Coordinate Management Review, Internal and External Audits
- In 2004, Zero Non-conformances (483's) in FDA audit
- Support DR facility in FDA Audit with Zero non-conformances (483's)
- Participate as Corporate Quality Auditor in facilities (CS- Ontario California)
- Assured recertification of ISO standard with TUV as Notified Body every year
- Implementation of cleanroom class 10 and class 100 for industrial garments in packaging
- Implementation of Corrective & Preventive Actions for customer complaints
- Managed support to China and Dominican Republic Operations
- Support in the implementation of LEAN Manufacturing: 8D's problem solving system, FMEA, Plan of Control, 10 D's housekeeping, 5S's in quality department
Quality Superintendent
Cardinal Health
Juarez
04.1995 - 12.1996
- Managed one facility with 100 employees
- Managed the quality department
- Assured compliance with quality corporate manual
Quality Engineer
Cardinal Health
Juarez
07.1994 - 03.1995
- Assure compliance with the Quality System
- Documentation control: Specifications, procedures, forms, etc...
- Development of quality systems (Management review, labels control, etc.)
Buyer / Planner for Raw Material
Westinghouse Electric Corporation
Juarez
03.1992 - 06.1994
- Implemented purchasing section of ISO 9001
- Supply raw material to the manufacture process
- Reduce pricing on raw material
- Relocate close suppliers to El Paso
Manufacturing Supervisor
Westinghouse Electric Corporation
02.1991 - 02.1992
- Responsible for produce Dry Type control transformers with 30 operators
Quality Assurance, Engineer
Westinghouse Electric Corporation
07.1989 - 01.1991
- Responsible for quality assurance department for 2nd. Shift with 300 employees And 6 persons as headcount
Quality Training Engineer
Westinghouse Electric Corporation
08.1988 - 06.1989
- Provide training to the new operator on winding process, packing, testing, etc...
Education
B.S. - Electro-mechanical Engineering
Instituto Tecnológico de Ciudad Juárez
Skills
- Results oriented
- Highly effective in Teamwork
- Able to work Under Pressure
- Highly Motivated
- Bilingual Spanish - English
- Able to manage people effectively
- Regulatory compliance
- Quality management
- Audit coordination
- Problem solving
PERSONAL RECOGNITIONS:
Excellence Award for Performance in 2004; Cardinal Health, Other recognitions for key projects participation in some years
SEMINARS:
- Bullet Proof Manager seminar
- ISO 13485:2016 Lead Auditor
- Six Sigma Certified Quality Engineer by Baxter Healthcare Corp.
- Lean Manufacturing seminar
- Sponsor training for Lean Six Sigma
Timeline
Quality and Regulatory Affairs Mgr.
Cardinal Health
09.2014 - 06.2026
Quality and Regulatory Affairs Manager
Cardinal Health
10.2008 - 08.2014
Group Quality Manager
Cardinal Health
06.2005 - 10.2008
Quality Manager
Cardinal Health
01.1997 - 06.2005
Quality Superintendent
Cardinal Health
04.1995 - 12.1996
Quality Engineer
Cardinal Health
07.1994 - 03.1995
Buyer / Planner for Raw Material
Westinghouse Electric Corporation
03.1992 - 06.1994
Manufacturing Supervisor
Westinghouse Electric Corporation
02.1991 - 02.1992
Quality Assurance, Engineer
Westinghouse Electric Corporation
07.1989 - 01.1991
Quality Training Engineer
Westinghouse Electric Corporation
08.1988 - 06.1989
B.S. - Electro-mechanical Engineering
Instituto Tecnológico de Ciudad Juárez