Luis Antonio Fimbres Gonzalez
Tijuana
Summary
Professional engineer with expertise in senior quality roles, process optimization, and compliance. Skilled in problem-solving, product integrity, and driving continuous improvement. Known for fostering team collaboration and adapting to changing project needs. Proficient in quality assurance methodologies, risk management, and regulatory standards. Equipped to deliver exceptional results in any quality-focused position with positive attitude.
Overview
5
5
years of professional experience
Work History
Quality Engineer II / Sr. Quality Engineer (Secondary Packaging and Final Release Shipping process)
Medtronic El Lago
11.2023 - Current
- Company Overview: Aortic and Pulmonary Heart Valves
- Coordinated CAPA investigations related to critical systems for manufacturing and service
- Streamlined internal communication, fostering cross-functional collaboration between engineering, manufacturing, and quality teams.
- Executed preventive improvements within the manufacturing areas in charge with an audit readiness approach (OQW's)
- Trained and mentored junior engineers, providing guidance and direction.
- Generated product certification of assurance in compliance with regulatory agencies specifications for product introduction to new geographies
- Supervised and coordinated night shift quality inspector's activities
- Supported multiple manufacturing processes during night shift as first contact during quality events
- Achieved complaint trend analysis for potential manufacturing related complaints to provide the appropriate actions/response
- Improved customer satisfaction levels with timely resolution of non-conformance issues and effective corrective actions.
- Championed process improvements initiatives, leading to cost saving projects of around 100k USD.
Incoming Quality Engineer II
ICU Medical
05.2023 - 11.2023
- Company Overview: Infusion Therapy and Airway Management Products
- Managed and supervised RI inspector's activities and payroll for two shifts
- Generated raw material non conformance reports in collaboration with SQE with various material dispositions (RTV, UAI, Scrap, RWK)
- Coordinated the execution of FAI's for new and updated material
- Performed RI instruction form corrections to align practices and test method
- Collaborated in remediation projects involving TMV for measuring critical dimensions of molded components
Quality Engineer (Chemical Treatment, Primary Packaging and Sterilization process)
Medtronic El Lago
05.2022 - 05.2023
- Company Overview: Aortic and Pulmonary Heart Valves
- Developed knowledge in sterilization processes involving bioburden monitoring, chemical treatment of fresh tissue, microbiology assessments and optimal environmental manufacturing conditions according to ISO14644 and ISO14698
- Performed manufacturing assessments/DHR reviews for product complaints
- Approached different problems/events with Failure Modes and Effects Analysis (FMEA) as priority to ensure product and patients safety
- Generated various non conformance material reports related to environmental monitoring, mix ups, microbiology and machine/equipment failure
- Developed critical thinking regarding current practices/procedures, root cause analysis and product risk evaluations for the continuous improvement
- Collaborated in First Time Quality (FTQ) events of manufacturing areas
- Completed CAPA actions closure
- Coordinated investigations with sterilization, laboratory, manufacturing engineering, R&D and design assurance departments for timely material disposition
Manufacturing Engineer
Medtronic El Lago
05.2021 - 05.2022
- Company Overview: Coronary Catheters Business Unit
- Contributed on the hyper care of new COS manufacturing lines in ramp up stages
- Developed new standard work sheets to determine the IPK of new COS manufacturing lines in implementation stages
- Performed installation qualification reports and new equipment registrations
- Improved manufacturing procedures as a preventive action to reduce scrap/rejections in process
- Evaluated the implementation of new equivalent raw material.
- Performed Device history record corrections and improvements
- Performed data analysis to review the process behavior and trendings (cpk,ppk)
- Generated rework instructions and process reviews for NCMR reports
- Established communication with suppliers to modify drawing/specification documents to meet Medtronic requirements
- Completed fixture design and installation that reduced scrap in manufacturing lines
Internship
Medtronic El Lago
08.2020 - 05.2021
- Company Overview: Coronary Catheters Business Unit
- Performed change orders in Agile MAP platform involving BOMs, SWS's and DMR's
- Planned the design of new manufacturing lines layout (AutoCAD)
- Generated purchase orders for engineering fixtures and consumables stock
- Supported staff members in their daily tasks, reducing workload burden and allowing for increased focus on higher-priority assignments.
Education
Bachelor's Degree - Bioengineering
Universidad Autónoma De Baja California
Tijuana, Baja California, Mexico01.2020
English Diploma - English
UABC Facultad De Idiomas
Tecate, Baja California, Mexico01.2015
Skills
- AutoDesk (AutoCAD)
- Minitab
- Microsoft Office
- Additional Software (Agile MAP, SAP, GCH, Trackwise, Oracle)
- Root cause analysis
- Regulatory compliance
- Audit readiness
- Critical thinking
- Effective communication
- Corrective and preventive actions
- Process improvement
- Team collaboration
Languages
Spanish
Bilingual or Proficient (C2)
English
Advanced (C1)
Hobbies and Interests
- Motocross
- Gaming
- Weight lifting
Personal Information
Age: 27
Tourist visa
Timeline
Quality Engineer II / Sr. Quality Engineer (Secondary Packaging and Final Release Shipping process)
Medtronic El Lago
11.2023 - Current
Incoming Quality Engineer II
ICU Medical
05.2023 - 11.2023
Quality Engineer (Chemical Treatment, Primary Packaging and Sterilization process)
Medtronic El Lago
05.2022 - 05.2023
Manufacturing Engineer
Medtronic El Lago
05.2021 - 05.2022
Internship
Medtronic El Lago
08.2020 - 05.2021
Bachelor's Degree - Bioengineering
Universidad Autónoma De Baja California
English Diploma - English
UABC Facultad De Idiomas
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