Eduardo Rodriguez

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Quality Engineer

Eduardo has 2 years of experience in engineering and manufacturing in the pharmaceutical and medical device industries.  He also has expertise in the development and execution of validation protocols.

 

EXPERIENCE…
  • Delivered full validation projects crucial to the manufacturing of medical devices, including:
    o Installation Qualification (IQ),
    o Operational Qualification (OQ)
    o Performance Qualification (PQ)
    o Completion Summary Reports
    o Standard Operating Procedures (SOP)
    o Preliminary Maintenance Standard Operating Procedures (PMSOP)
    o Process Set-up Sheets
    o Manufacturing Instructions (MI)
    o User Requirements Specification (URS)
    o Process Failure Mode Effects Analysis (PFMEA)
    o Process Flow Diagram (PFD), Test Methods
    o Quality Impact Assessment (QIA)
    o Environmental Health and Safety Assessment
    o Traceability Matrix
    o Validation Plans
    o Project Timeline
    o Material Requisition Forms
    o Change Authorization Forms
    o Gage R&R
  • Directed training activities for over 700 company employees on procedures introduced to the manufacturing floor.
  • Saved half-million dollars annually in the use of low cost efficient raw materials.
  • Led validation efforts for various pharmaceutical and medical device operations, including equipment commissioning and validation master plans.
  • Developed engineering specifications and validated packaging equipment for medical device and pharmaceutical operations.
  • Facilitated development of defect classification activities driven by failure mode & effects analysis.
  • Created and implemented a new training program with 90% participation of employee population to enhance Good Manufacturing Practices.
  • Increased machine production by 20% with the completion of time studies.
  • Assisted in the introduction of Regulatory Asset Manager (RAM) program into the company for improvements of inventory control.
POSITIONS HELD…
  • Quality Engineer – BioTeknica, Inc.
  • Manufacturing Engineer – CareFusion Corporation
  • Engineering Intern – CareFusion Corporation

 

EDUCATION…
  • M.S., Electrical Engineering – The University of Texas at El Paso
  • B.S., Electrical Engineering – The University of Texas at El Paso
CONTINUING EDUCATION…
  • AutoCAD
CERTIFICATIONS…
  • Six Sigma – White Belt