Emanuel Abundez

Experience

• 

  The University of Texas - Pan American

  Jan 2013 - Jan 2013

  Teaching Assistant - Material Laboratory
• 

  Weatherford

  Jan 2014 - Apr 2016

  Professional Services Engineer

  • Construct HMI screen for operators to help improve process and production of gas and oil production.• Assist in programming and troubleshooting PLC's and other remote devices• Derive a method to calculate future inventory based on current flow data • Developed reports to assist plant managers to asset overall health of the plant• Utilized HMI to monitor critical data • Use PLC's to monitor thermal activity in wells

• 

  Smith+Nephew

  Apr 2016 - now

  Provide quality leadership to product support project teams as thequality engineering representative. Work with a team to develop methodsand procedures to ensure that the appropriate tests are conducted to assurethat products meet the required specifications/standards and that the safetyand reliability of products are established. Generate/approve/manage designverifications, design validations, sterilization validations, process validations,supplier qualifications, test methods, capability studies, and riskmanagement documentation.Support establishing contract manufacturer and internalmanufacturing operations. Provide expertise in product requirements, riskmanagement, test methods, and statistical analysis. Ensure compliance to product specific standards, including but notlimited to: cGMP, QSR, US FDA, ISO, IEC, UL, EN, EU MDR and MDDrequirements. Ensure that all the responsibilities within the scope of this jobcomply with the scope of the Quality System.Work with outside labs and suppliers to communicate Smith & Nephewproduct / process requirements as well as assess capabilities of the outsidelab / supplier. Support Management Review, internal/external audits/inspections,continuous improvement activities (CAPA), and Post Market Surveillanceactivities. Meno dettagli • Provide quality leadership to sustaining project teams as the quality engineering representative and procedures to ensure that the appropriate tests are conducted to assure that products meet the required specifications/standards and that the safety and reliability of products are established.• Generate/approve/manage design verifications, design validations, sterilization validations, process validations, supplier qualifications, test methods, capability studies, and risk management documentation.• Support manufacturing operations and provide expertise in product requirements, risk management, test methods, and statistical analysis including measurement system analysis.• Ensure compliance to product specific standards, cGMP, QSR, US FDA, ISO, IEC, UL, EN, and MDD requirements. Ensure that all the responsibilities within the scope of this job comply with the scope of the Quality System.• Work with outside labs and suppliers to communicate Smith & Nephew product / process requirements as well as assess capabilities of the outside lab / supplier.• Support continuous improvement activities (CCRs and/or PARs).• Support Post Market Surveillance activities, Management Review, and audits/inspections.• Assist in reviewing and the closure of the complaint process.• Support Measurement System Analysis studies Meno dettagli • Developed instructions for Critical to Quality determination methods with a cross-functional team.• Provided quality leadership to sustaining project teams as the quality engineering representative and ensured that the appropriate tests were conducted to assure that products meet the required specifications/standards and that the safety and reliability of products were established.• Generated/approved/managed design verification, design validations, sterilization validations, process validations, supplier qualifications, test methods, capability studies, and risk management documentation.• Supported manufacturing operations by providing expertise in product requirements, risk management, test methods, and statistical analysis including measurement system analysis.• Ensured compliance to product specific standards, cGMP, QSR, US FDA, ISO, IEC, UL, EN, and MDD requirements. Ensured that all the responsibilities within the scope of this job comply with the scope of the Quality System.• Worked with outside labs and suppliers to communicate Smith & Nephew product / process requirements as well as assess capabilities of the outside lab / supplier.• Supported Post Market Surveillance activities, Management Review, and audits/inspections Meno dettagli

  • Senior Design Quality Engineer

    Mar 2021 - now

  • Design Quality Engineer 2

    Jan 2018 - Mar 2021

  • Quality Assurance Engineer I

    Apr 2016 - Jan 2018