Rubi Torres-Davila

Experience

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  EDIASA

  Jan 2003 - Jan 2006

  Launch Coordinator
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  Ethicon-Endo Surgery

  May 2006 - Jul 2009

  Manufacturing Engineer

  o Performing activities related with troubleshooting of automated and mechanical assembly systems.o Experience in manufacturing process design projects from concept to implementation.o Understanding of Lean Manufacturing and SPC ideologies.o Coordinating all logistics related with engineering changes.o In charge of all activities involved in a Master Validation Plan (Installation Qualification, Operational Qualification, Performance Qualification and Software Validations).o Responsible of ensuring personal and company compliance with Federal, State, local and company regulations, policies and procedures for Health, Safety and Environmental compliance.o Responsible to ensure and improve GMP quality system compliance within the work area.o Planning direct manufacturing functions to include labor allocation, adherence to process specifications, continuous flow, manufacturing, housekeeping, and other areas as required.o Performing line balancing to support continuous flow concepts in production lines.o Actively leading a Performance Measurement System along Independencia Plant.o Leading a Supermarket project. Show less

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  CareFusion

  Jul 2009 - Dec 2010

  Senior QA Engineer

  o Actively participating in the validation process of processes, products, and equipment. Including MVP, IQ, SQ, OQ, & PQ.o Creating and maintaining the Risk Management Procedure along with PFDs, PFMEAs DFMEAs, and Control Plans.o Performing First Article Testing on new or revised raw materials.o Performing, reviewing and approving engineering tests in support of all departments.o Perform statistical analysis and recommend strategies to quality plans.o Supporting compliance program to include leading internal audits and interface with customer, BSI and FDA auditors.o Reviewing, verifying and maintaining the validation programs for the manufacturing, engineering, R&D, sterilization, and laboratory departments.o Developing annual re-validation procedures.o Providing: Trouble shooting support and corrective action support to steady state operations when needed.o Actively participating in the CAPA responsiveness for customer related issues.o Primary responsibilities include overseeing quality development systems and planning in support of R&D as it relates to the manufacturing, distribution, laboratory and sterilization functions.o Evaluating engineering tests in support of validation programs as needed and as it relates to the manufacturing, R&D, laboratory and/or sterilization projects.o Maintenance of new Fact Books. Show less

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  GE Healthcare

  Dec 2010 - Aug 2015

  o In charge of two plants (Juarez and El Paso sites) CAPA System/Process.o Providing Corrective and Preventive Action (CAPA) process leadership driving improvements in product and process performance, and elimination of waste. o Responsible for the effectiveness and efficiency of the Corrective and Preventive Action Process and System. o Accountable for performance of CAPA system and metrics providing direction and leadership for the CAPA process. o Providing leadership to the CAPA Review Board to achieve quality goals.o Developing and implementing an ongoing education program for the CAPA process and developing and implementing measures to monitor the effectiveness of the CAPA process and driving remediation for improvement.o Responsible for organizing and coordinating the Corrective and Preventive Action Process evaluation, investigation and implementation teams for root cause analysis and corrective and preventive action. o Responsible for effectively manage and improve the CAPA process and system for tracking, trending and reporting and will ensure CAPA process execution, accountability, and due diligence. o Ensuring that trends are analyzed and CAPA's initiated and completed as required. o Responsible for reporting on a monthly and quarterly basis against established measures and providing the status of CAPA performance to Executive Management Review process. o Driving continuous improvement through the CAPA process while interfacing closely with key members of management, the CAPA Process Owners, to facilitate the effectiveness of the Corrective and Preventive Action Process. o Process Owner for escalation of quality issues, drive process improvements and ensure execution to process. Show less o Reviewing and approving validation documents for simultaneous product transferences from other GE Plants, New Products Introduction and Engineering Changes, ensuring compliance with FDA regulations.o Approving and assessing Risk Management documents.o Managing the Incoming Inspection activity at the Distribution and Configuration Center. These activities including: o Current items Incoming Inspection.o New items First Article Inspection.o Managing all activity in regards to Quality and Regulatory holds for the Distribution Center, involving more than 50 countries, and up to 2000 different product configurations, supplies and accessories.o Supervising RMAs area including the following activities:o Out of Box Failure investigation.o Customer Complaints investigation.o Order Cancellation records.o Responsible of the CAPA system at the Configuration and Distribution Center.o Continuously providing support to the Manufacturing , Configuration and Distribution sites by troubleshooting the production systems to solve quality related issues. Show less

  • CAPA Site Leader / QA Lead Engineer

    Dec 2012 - Aug 2015

  • Lead Quality Assurance Engineer

    Dec 2010 - Dec 2012
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  STERIS Isomedix Services (Now STERIS AST)

  Aug 2015 - now

  • Sr. Director, Quality Systems

    Apr 2024 - now

  • Quality Systems and Regulatory Compliance Director

    Jul 2019 - Apr 2024

  • QS/RC Manager

    Aug 2015 - Jul 2019