Experience

Merit Medical Tijuana

• Medical Equipment Manufacturing
• 1 - 100 Employee

• Senior Quality Assurance Engineer I

  • Jun 2022 - Present

  - Quality Representative for a Bussiness Unit with aprox. 500 associates / 20 production lines.- Plan, organize, mentor, and supervise the work of engineers and technicians on various engineering projects and quality system compliance issues. HC: 2 Engineers, 1 Technician, 18 Inspectors.- Responsible for coordinating risk analysis/management activities following up to ensure risk mitigation and facilitating improvements.- Support Internal Audit and supplier audit activities, performing audits, writing audit reports, and following up on effectiveness of corrective/preventative actions.- Customer Complaints, NCs, CAPAs investigation/implementation responsible. Show less

• Quality Assurance Engineer III

  • Jun 2021 - Jun 2022

  • Project Management responsible for the QA department activities (Projects/Transfers).• Worked around barriers which prevented objectives from being achieved during validation phases of a product transfer. • Collaboration within different departments to achieve their assigned tasks.• Lead multidisciplinary teams to solve manufacturing issues.• Tier I, II & III coverage for the projects.• MDR support for PMS documentation (PMSP, PMSRR, PSUR)• Strong collaboration across merit individuals from different departments (regulatory, marketing, PMS, clinical, quality) to achieve plant goals).• Coordinate Marketing team to adjust/improve a cosmetic criteria for product transfer.• QRMT activities support for sustaining team during MDR focused stage at the end of 2021. Show less



Flex

• United States
• Appliances, Electrical, and Electronics Manufacturing
• 700 & Above Employee

• Sr Quality Engineer

  • Aug 2019 - Jun 2021

  • Diagnostics and Guides Intravascular Catheters sub-assembly and Molding process experience.• Lead CAPA teams to solve manufacturing issues.• Lead weekly meetings with the customer to follow up/track area metrics (Yields, NC’s, Production, Projects).• Lead Monthly CAPA meeting with the customer.• Acting as sustaining and project QA engineer for Molding area by supporting with the validation strategy definition, planning and execution (PQ validations protocol/execution/reporting).• Training QA Interns in the area and monitor their development. Show less

• Quality Engineer

  • Jul 2017 - Aug 2019

  - Diagnostics and Guides Intravascular Catheters sub-assembly process experience.- Diagnostics and Guides Intravascular Catheters Molding process experience.- Sustaining activities for production floor such as leading Non conformance investigation, containment and disposition activities. - Lead CAPA teams to solve manufacturing issues. - Customer Complaints investigations and response. - Projects support as Creator/Executor for validation reports (PQs).- Annually cost savings of $20K dlls by performing a Sampling plan reduction.- Achieve a plant record of 15 weeks with 0 NCMRs.- Experience in audits for FDA / ANVISA as SME on Class 3/Class 1/PMA products. Show less

• Manufacturing Engineer

  • Mar 2016 - Jul 2017

  - New supplier validation, cost saving of 800k USD annually.- Validation process of interplant transfers and local equipment (IQ's, OQ’s and PQ's)- In charge of the investigation of customer complaints based on the manufacturing process among the quality team.- Special Focus on Customer Success & Satisfaction.- Engineering changes including documentation and process.- Continuous improvement Projects- In charge of monitoring and reducing Scrap of the production lines- Project Management through teamwork distribution, weekly goals and monthly reports. Show less



Springs Window Fashions

• United States
• Manufacturing
• 700 & Above Employee

• Lean Manufacturing Ops Leader

  • Oct 2015 - Mar 2016

  - Directly in charge of an operation team of 40 persons including operators, quality inspectors and process trainers. - Leader of manufacturing projects for flow improvement raising the manufacturing lines up to 48% by line balance. - Continuous improvement (MDI, PDCA). - Scrap monitoring - Strongly focused on Schedule attainment and Efficiency - Directly in charge of an operation team of 40 persons including operators, quality inspectors and process trainers. - Leader of manufacturing projects for flow improvement raising the manufacturing lines up to 48% by line balance. - Continuous improvement (MDI, PDCA). - Scrap monitoring - Strongly focused on Schedule attainment and Efficiency



Fisher & Paykel Healthcare

• New Zealand
• Medical Equipment Manufacturing
• 700 & Above Employee

• Operations Engineer

  • Jan 2015 - Aug 2015

  - Validation process: IQ, OQ & PQ. - In charge of the investigation of customer complaints based on the manufacturing process. - Continuous improvement (PDCA, DMAIC, A3) - In charge of monitoring and reducing Scrap of the production lines (GABI) - Project Managment - Validation process: IQ, OQ & PQ. - In charge of the investigation of customer complaints based on the manufacturing process. - Continuous improvement (PDCA, DMAIC, A3) - In charge of monitoring and reducing Scrap of the production lines (GABI) - Project Managment



Fisher & Paykel Healthcare

• New Zealand
• Medical Equipment Manufacturing
• 700 & Above Employee

• Engineering Intern

  • Sep 2013 - Nov 2014

  -MCS/MC (Maintenance Software) -Training staff on the use of new software. -In charge of maintenance records -Preventive and Critical Maintenance (Work Orders Review) -Translation of controlled documents. -Validation Process (only IQ). -Project management through teamwork distribution, weekly goals and monthly reports. -MCS/MC (Maintenance Software) -Training staff on the use of new software. -In charge of maintenance records -Preventive and Critical Maintenance (Work Orders Review) -Translation of controlled documents. -Validation Process (only IQ). -Project management through teamwork distribution, weekly goals and monthly reports.



Custom Sensors & Technologies (CST)

• United States
• Appliances, Electrical, and Electronics Manufacturing
• 1 - 100 Employee

• Automation Project Engineer Intern

  • Mar 2014 - Jun 2014

  The objective was to automate a production line in order to achieve the class credits on Industrial Automation & Robotics subject. -PLC Programming (CX Programmer) -Basic use of Neumatics components -Electric diagrams interpretation and implementation The objective was to automate a production line in order to achieve the class credits on Industrial Automation & Robotics subject. -PLC Programming (CX Programmer) -Basic use of Neumatics components -Electric diagrams interpretation and implementation