Highlights:24+ years of experience in Quality Positions. Medical Devices (16 years) automotive (6 years), electronics (2 years). • 7+ years of experience in Quality Management with up to 32 direct reports. Achieved regulatory FDA, ANVISA and JPAL registration and standard certifications such as ISO: 9001:2015 and ISO 13485:2016. • Experience as a Quality Manager, Compliance Manager, Supplier Management (working with suppliers and/or contract manufacturers for medical devices), CAPA Coordinator, Process & Software Validation Engineer, Supplier Quality Engineer, Quality Engineer, Manufacturing Team Leader, Lead Auditor. • Lead Auditor experience (70+ Supplier audits). • Collaborative, accountable team bi-lingual player with ownership mentality and a track record of delivering the highest quality strategy to quickly assess problems and find solutions.

Skills:Engineer, Six Sigma, CAPA, FDA, ISO 13485, Regulatory, ISO9001, Validations, Quality Systems, Supplier Management, Risk Management, Quality Improvement, Leadership, SPC, Quality Assurance, Quality Control, APQP, Control Plan, PFMEA, Lead Auditor

Goal:Continue my leadership role experience with the support of a Company sponsorship.

Certification:Bachelor’s degree of industrial Engineering @ Universidad Cultural Cd Juárez Chih. Juarez Mex, Dec 2000. 6 sigma-Green-Belt- Certified @Tecnológico de Monterrey, Cd Juárez Fol:15198 Leadership: BARD OPERATION LEADERSHIP TRANSITION 2016, “Effective Supervision” training by CAPINTE, 2014, “Professional Project Manager” Training PMI PMBOK-Based project management instruction, by Bridgegap Consulting, August 2013. Regulatory for Medical Devices: ISO 13485:2016 and ISO9001 Internal Auditor Certified by BSI, US FDA 21 CFR Part 820, EU MDR, ISO 14971: 2019 EN ISO, ANVISA requirements, QMSR for Japan requirements, China FDA GMP Regulations, Taiwanese Pharmaceutical Affairs Act, MDSAP, Technical Manufacturing: Ergonomic MTM Certification, Statistical Control Seminar, Problem Solving Training (DMAIC/CAPA/8d/5d/5W/PDCA), PPAP process (APQP/MSA/PFMEA/CP), KAIZEN.

Supplier Quality Auditor May/2020 - current
BEPC Inc., Mission Viejo, California United States
Industry: Contractor
BEPC Inc. (SUPPLIER QUALITY AUDITOR ON BEHALF OF JOHNSON AND JOHNSON REGULATORY COMPLIANCE)
BEPC Inc. (SUPPLIER QUALITY AUDITOR ON BEHALF OF JOHNSON AND JOHNSON REGULATORY COMPLIANCE) Responsible of planning and executing Remote or Onsite Supplier Audits for Indirect/Direct and finish Product, ASL suppliers on behalf of Johnson and Johnson Operating Companies JJRC (Ethicon, Synthes, Mentor, DuPuy, Vision Care, Megadyne, Biosense Webster etc.…). General scope overview is for suppliers doing repetitive, Job shop, continuous and batch manufacturing for medical devices components using general assembly, extrusion, molding, SMT, IT services, Calibration services, Laboratory testing, and sterilization services.--
QUALITY ASSURANCE MANAGER FOR MEDICAL DEVICES Oct/2017 - Mar/2020
FLEX HEALTH SOLUTIONS, Cd Juarez, Chihuhua Mexico
Industry: Manufaturing
FLEX HEALTH SOLUTIONS, (PRECISION INJECTION MOLDING, CUSTOM MOLD MANUFACTURING WITH CLASS 7 AND 8 CLEAN ROOMS, MACHINING, NYLON, ANODIZING PROCESS, SILKSCREEN PRINTING ASSEMBLY)
Responsible to stablish and maintain key performance indicators, including monitoring and interpretation of potential risks: o Manage yield indicators (in-process and final inspection) through daily (GEMBA) meetings. Achieved lot acceptance rate. o Responsible to work in alignment with customer and gather product feedback/complaints. Improve by reducing complaints metric and finish 2019 with an improving trend. o Implemented and maintained effective CAPA process focused on reduction of causes of customer complaints, non-conformances, excursions, rejections, and waste. (Including CAPA Review Board) o Achieved a Quality Supplier Management yield at Incoming Inspection area. (Internal Yield). o Achieved a 100% plan Completion for Management Reviews required per schedule. o Coordination of internal audits per schedule. o Responsible to coordinate two Mock audits per year. (Per FDA requirements) o Achieved zero number of major observations from external audit (e.g., FDA 483 or Warning Letter, major observations from notified bodies, etc.) Achieved implementation of continuous improvement quality systems and business processes, including product controls to achieve quality goals and to maintain a high level of regulatory compliance. (Six sigma, PDCA, SPC etc.). Responsible to Interface with Regulatory Agencies (ISO notified body, other foreign regulatory bodies). Responsible to Lead and support customer audits, corporate audits, FDA inspections, and internal audits. PROJECTS: 1. Achieved regulatory and standard certification implementation for ISO: 9001:2015 and ISO 13485:2016, FDA registration, ANVISA registration and JPAL registration. 2. Implementation and construction of Document Control Area and DHR record retention area as well as product release process. 3. Responsible for new Software introduction upgrade for electronic document control process. (Master Control) 4. Support the CGMP compliance activities and continual optimization of control systems for new product introduction.--

Universidad Cultural 07/1998 - Dec/2003
Cd Juarez, Chihuhua, Mexico
Degree: Bachelor's Degree
Major:Industrial Engineer
Minor:Quality Systems
Bachelor’s degree of industrial Engineering @ Tecnologico de Cd Juarez but transferred to Universidad Cultural Cd Juárez Chih. Juarez Mex to obtain the official title degree.

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