Jesús Daniel Gutiérrez Fierro
Loxahatchee Groves
Summary
Results-driven Quality Engineer specializing in CAPA management and process optimization. Leads cross-departmental collaboration and enhances compliance auditing. Skilled in data analysis and developing customer-focused solutions, contributing to improvements in quality assurance initiatives. Team-minded coordinator with several years of comprehensive experience performing administrative support duties to help office run smoothly. Versed in maintaining up-to-date files, preparing and recording invoices and initiating and managing payroll. Tech-savvy and hardworking professional knowledgeable in office management and bookkeeping procedures.
Overview
12
12
years of professional experience
1
1
Certification
Work History
CAPA COORDINATOR, STAFF QUALITY ENGINEER
Johnson & Johnson
Palm Beach Gardens
05.2022 - Current
- Manage the CAPA processes for the site, coordinating the failure investigation process and ensuring communication among different departments (QA, Operations, Engineering, Complaints, receiving inspection, etc.) to achieve a robust and effective action plan.
- Managed the overall effectiveness of the CAPA processes by leading and facilitating relevant data review forums.
- Led Management Review meetings at Palm Beach Gardens site to ensure compliance and address quality issues.
- Facilitated Quality Progress Report process, delivering insights on quality performance and identifying areas for improvement.
- Facilitated reliability forums to evaluate quality concerns weekly and ensure customer-focused solutions.
- Supported external audits as CAPA Subject Matter Expert, enhancing understanding of CAPA processes.
- Acted as Subject Matter Expert for the ETQ CAPA system at the Palm Beach Gardens site to optimize processes.
- Support on validation activities as part of the action plans to address Root Causes.
- Depuy Synthes, Palm Beach Gardens
CAPA COORDINATOR/ Transfer - NPI Quality Engineer, SR QUALITY ENGINEER
Johnson & Johnson
Juarez
03.2018 - 04.2022
- Coordinated compliance transfer of products from Miramar, FL site to Cerenovus JRZ, ensuring adherence to quality standards.
- Manage the CAPA processes for the site, coordinating the failure investigation process and ensuring communication among different departments (QA, Operations, Engineering, Complaints, receiving inspection, etc.) to achieve a robust and effective action plan.
- Responsible for the overall management and effectiveness of the CAPA processes, including leading and facilitating relevant data review forums.
- Facilitated on-time closure of the NR process, aligning with defined metrics to support site compliance.
- Tracked and analyzed product performance and evaluation results, providing insights for CAPA escalation.
- Leadership of the Management Review process for BWI and Codman Juarez site.
- Leadership of the Data Review Process (DRB) for BWI Jrz.
- Educated and mentored team members on Quality Systems, focusing on foundational and ongoing training.
- Support as CAPA SME during audits for external bodies.
- Biosense Webster Inc, Juarez Site
QUALITY ENGINEER II
Johnson & Johnson
04.2016 - 02.2018
- Supported JJRC and BSI audit readiness programs.
- Quality representative/supervisor for Split Flow and D&A Production Lines.
- Front Room/ Back Room Experience for JJRC and MDSAP audits.
- Supervised raw material inspection technicians and coordinated QA hold cage flow for rejected production materials, ensuring efficient handling of non-conforming materials.
- Served as QA representative for Rapid Response Team across G9 countries (China), implementing corrective and proactive actions with a focus on quality assurance in China and Japan.
- Maintain site Leadership for China SC team and active support to Japan SC team.
- Perform weekly and monthly audits on production floor to audit the adherence to the GMPs.
- Support the site CAPA strategy. Acting as a CAPA member on the performing of activities and performing the effectiveness monitoring of CAPAs with product impacted or as part of a customer complaint.
- Coach and mentoring for QA group leaders for 1st and 2nd shift.
- Act as SME/Approver on validation of new codes/equipment including IQ/OQ/PQ development/ approvals.
- ECNT New machine for needle penetration testing lead of transfer/ Test method validation.
- Computer Software Validation development for New Automated swaged machines.
- Support on Plant Projects/ initiatives (JJPS, PDS Clear, Hurricane, etc.).
- MES (electronic DHR documentation system) SME for Quality Department.
- Perform evaluation to Automated manufactured equipment’s (FAS) to ensure that risks found in Puerto Rico and Scotland are mitigated/ Prevented in Engaged with Ethicon Inc teams to ensure quality standards were met. Jrz site.
- Perform the Robust Process Assessment to Split flow areas in Ethicon Inc.
- Developed procedures and action plans to maintain operations during MES system disruptions, minimizing potential customer impact.
- QA Support for New codes validation in China as part of the G9 action plans.
- Ethicon Inc
QUALITY ENGINEER
Johnson & Johnson
05.2014 - 04.2016
- Test method franchise validations performed for pull tester used across all families validated on Juarez site.
- Support on Combination products strategy in Juarez site (cleaning validation/ Leachables and Extractables/ Yield Calculation).
- Supervised and coached QA technicians on production floor, enhancing team skills and maintaining quality standards.
- Supported franchise/local CAPAs for Combination Product Remediation, ensuring compliance and timely resolution.
- Stop shipment process coordination for material rejected interplant (San Angelo, Juarez, Distribution centers).
- CAPA owner for Combinations products remediation in on environmental Conditions completed with all activities on time.
- Supported BU CIP projects through documentation, validation approvals, product disposition, and QA techs collaboration for testing and innovative project ideas.
- NCR reduction strategy (HER, DIR activities, NCRs approvals).
- Executed, enhanced, and tracked quality walks according to schedule.
- Executed test method validation processes to ensure accuracy and compliance with standards.
- HER reduction, active participation on initiatives defined.
- Collaboration with different sites (San Angelo, Juarez, Cornelia, Somerville) to perform the activities related as part of the combinations products Remediation.
- IQ/OQ development/ approvals.
- Execution and Final approvals for NR’s of In process quality issues.
- Credo Activities lead/ Support.
- Ethicon Inc
Education
Industrial Engineer - Quality and Productivity
Instituto Tecnológico de Ciudad Juárez
Cd. Juárez, Chihuahua06-2013
Skills
- Quality Assurance
- Process Optimization
- Statistical Analysis
- Data analysis
- JDE
- Decision making
- Adapts under pressure
- Collaboration skills
- Leadership Attitude
- CAPA management
- data analysis
- root cause analysis
- quality assurance
- product validation
- compliance auditing
- cross-departmental collaboration
- external audit support
- problem solving
- customer-focused solutions
- Regulatory compliance
- Strategic planning
Certification
- Certified ASQ-CQE, #102755
- JJQE certified, 2018
- J&J Green Belt trained, 2018
Professional Target
To contribute inside of the laboral environment to the success from myself and the company, contributing skills, abilities, knowledge, time and effort to get the success through making goals and different targets, all this in order to improve in my growth as professional and contributing to position the company in the highest level of competitiveness possible.
Timeline
CAPA COORDINATOR, STAFF QUALITY ENGINEER
Johnson & Johnson
05.2022 - Current
CAPA COORDINATOR/ Transfer - NPI Quality Engineer, SR QUALITY ENGINEER
Johnson & Johnson
03.2018 - 04.2022
QUALITY ENGINEER II
Johnson & Johnson
04.2016 - 02.2018
QUALITY ENGINEER
Johnson & Johnson
05.2014 - 04.2016
Industrial Engineer - Quality and Productivity
Instituto Tecnológico de Ciudad Juárez