Claudia Lopez

Experience

• 

  Creation Technologies

  Aug 2014 - Mar 2016

  ▪Schedule programs for production on time and on budget.▪Generation and completion of production jobs in Oracle and Vision.▪Fully involved in Inventory activities.▪Production planning; monthly and weekly planning to achieve customer and internal goals.▪Assembly line balancing; I am in charge of 5 customers so I have to use the same people for different activities.▪SOPR review; Ensure materials availability.▪OTD; always seeking the best score for OTD.▪PO review; Constant communication with customers to review open PO’s and production priorities. Show less ▪Customer Service from a CFT model.▪Lead role in the CFT, Operations and engineering teams on issues related to internal, customer and supplier non-conformances and Corrective Actions Requests.▪Create and maintain 5S methodology in assigned areas.▪Corrective Actions using 8D format.▪Generate periodic Quality data for internal or external customer review.▪Ensure quality procedures are being followed.▪ PPAP documentation – PFMEA, Control Plan and Process Flow creation.▪Identify process improvements due to Quality data such as Yield data.▪Internal Quality Audits to Document Control, Supply Chain, Measurement, Analysis and Improvements.▪Creation of work instructions.▪Process changes and NP development; Assisted in a transfer from another BU.▪Process improvements; improving production changing the process from manual into wave solder machine creating fixtures.▪ UL, FM, TUV, CSA and VDE certifications; I leaded the introduction of new certifications into the company for a customer requirement.▪ Layout projects Show less

  • Program Leader

    Jun 2015 - Mar 2016

  • Quality Engineer

    Aug 2014 - Jun 2015
• 

  ICU Medical

  Mar 2016 - now

  Coordinates efforts to provide support in activities related to Supplier issues to maintain and improve product quality for Medical devices.• Score card update and Supplier Escalation Activities• Supplier Qualification Activities• Follow up with Suppliers SCARs response. Corrections required after a nonconformance is found.• Ensures material received it is according to specification• Follow up NCMR’s completion.• Advises quality engineers, supervisors, quality leaders and inspectors on problem resolution.• Verifies that according to the production priorities program, the available resources of personnel and equipment are assigned to meet the production goals.• Takes immediate action to correct any deviation from procedures corresponding to their area.• Provides support for quality complaint investigations assigned to the Ensenada plant corresponding to supplier components, as well as ensures that corrective and preventive actions are implemented to avoid further customer complaints due to supplier sourced problems.• Active participation on Corporate and ISO Audits – 0 observations.• Lead Auditor – Active participation in Supplier Audits and Corporate Audits. Show less Coordinates efforts to provide support in all related Quality Activities to maintain and improve product quality for Medical devices. • Provides clear assignments, creates an inclusive work environment characterized by mutual respect and builds a culture that motivates employees to their highest levels of performance. • Lead for process risk management activities, supporting product investigations.• Be a champion of quality excellence.• Ensure that communication from QE department is effective and thorough.• Provides support in Design Activities• Full involvement in Controls Changes Activities• Create/ Update Internal Procedures as required• Internal Auditor Show less Perform Validations as required and Quality Team Administrator.• Process, Product, Equipment, Aging and Packaging Validations.• Quality Plan Execution; Determine project deliverables and project closure.• Team Leader in Multidisciplinary group; • P FMEA trainer.• Risk Assessment execution and Market Action Implementation collaborator • Engineering Change Proposal’s administrator, reviewer and approver • CAPA Owner and executer• Test Method Validation• GAP and Re-validation Assessment coordinator and executor• Root Cause Analysis during Non-Conformity Reports on the Assembly Process.• Statistical Analysis, Gage R&R, Hypothesis Test, T-test, Variance, Normality Test, CPK• Cost Reduction Projects Show less

  • SUPPLIER QUALITY AREA MANAGER

    Mar 2022 - now

  • Quality Engineer Area Manager

    Jul 2019 - Mar 2022

  • Quality Assurance Engineer

    Mar 2016 - Jul 2019