David Llana

Email: abqkse@r.postjobfree.com

Address: ***** ***** ***** ******

City: PEMBROKE PINES

State: FL

Zip: 33331

Country: USA

Phone: 954-***-****

Skill Level: Experienced

Salary Range: $80,000

Primary Skills/Experience:

See Resume

Educational Background:

See Resume

Job History / Details:

David A. Llana

SUMMARY

* Process Validation including IQ,OQ and PQ

* Quality System Compliance for ISO 13485:2009 and 21CFR820

* CAR (Capital Appropriation Request)

* Cost Effective Solutions

* Part Tracking in JDE

* Root Cause Analysis

* Non-Conformance Reporting

* QIP (Quality Improvement Plan)

* QIR (Quality Investigative Report)

* Change Management System

* English-native, fluent in Spanish and French

* MS Project, Word, Excel, PowerPoint, Outlook

EXPERIENCE

October 2011- Present Zimmer Inc.

Quality Engineer II Warsaw, IN

* Developed a cost effective solution for continuous amperage monitoring of all Ramco Sonic Clean units beginning from testing of new solution, proof of concept, and presentations to senior upper management and value stream managers, vendor quotations, change management system, protocol drafting, implementation and qualification.

* Project lead for upgrade of Ramco Sonic Clean units by retrofitting with flow switches, flow meters, an HMI (Human Machine Interface) and PLC (Programmable Logic Controller) for alarming and process monitoring conditions

* Project lead for upgrade of Miele Washer(s) Profitronic Operating System from version 4.05 to 5.02

* Managed Calibration of Miele Washers for Soap Concentration, Time, and Temperature

* Managed Calibration of Amperage on current sensors for Ramco Sonic Clean Units

* Managed Calibration of critical gauges such as flow meters on Ramco Sonic Clean Units

* Identified equipment performance malfunction resulting in the issuance of a QIR (Quality Investigative Report)

* Proposed and implemented various alarming conditions for Ramco Sonic Clean Units to ensure best process control

* Performed testing on equipment using Kaye Validator 2000 including temperature mapping, thermal surveys, data analysis, while providing calibration, qualification, and calibration verification reports

* Generated and executed process validation protocols including IQ, OQ, and PQ

* Established recommendations for on-site procedures to ensure the highest possible quality and adherence to the quality system, FDA, GDP,GMP, and ISO standards

* Ensured quality assurance through inspections and maintenance of proper records and documentation for audits

* Supported medical device quality departments through process validation efforts within a team of engineers

* Interfaced with Vacuum Furnaces throughout the Diffusion Bonding Process analyzing Temperature Trend Charts and Vacuum Trend Charts

* Managed the Operational Qualification of the Upper Specification Limits and Lower Specification Limits for orthopedic implant products

* Assembled orthopedic implant products into graphite fixtures prior to the Diffusion Bonding Process

* Assembled Trabecular Metal World Cups and Continuum Cups into fixtures prior to the Diffusion Bonding Process

* Proposed and implemented furnace load configurations of all orthopedic products including thermocouple locations

* Organized validation dossiers containing all pertinent information such as: Furnace Cycle Reports, Heat Logs, Temperature Trend Charts, Vacuum Trend Charts, Data Log Sheets, Furnace Cycle Profiles, Holography Images,, Biomechanical Lab Test Reports, Device Routers, Pad Routers, etc for submission to the FDA for audit as part of FDA Remediation

* Part tracking, reporting, scrapping of parts utilizing JDE

* Generated Non-Conformance Reports for scrapped parts

* Devised a Disaster Recovery Plan to ensure Ramco Sonic Clean units can be fixed by the maintenance department rather than the vendor. This includes: PLC installation and configuration, HMI configuration and installation, & alarm log clearing

* Monitoring of flow switch functionality on Ramco Sonic Clean units to ensure proper function by analyzing data gathered from an amprobe

* Execution of IQ Protocol on Miele Washers including: Low Soap Detection Test, Soap Dispense Volume Test, Thermal Surveys, Cleanability Test, DI Water Volume Test, Air Pressure Test

* Programmed Miele Washers with set parameters for all execution of validation tests

January 2010-October 2011 Florida Department of Transportation

Traffic Management Center Consultant Miami, FL

* Performed Quality Control on District 6 Traffic Report Summaries on a weekly basis

* Completed Quality Control for DMS Usage Report, SEFRTOC Report, ITS Maintenance Report, Website Statistics Report, FLATIS Report, IT Hardware and Software Report, Express Lanes Monthly Report, Error to Event Ratio Report, ITS Operations Summary Report, Sunguide Software Report, Backup Location Report, ITS Locate Devices Report and IT Inventory on a quarterly basis

* Drafted and Updated all Standard Operating Guidelines for the aforementioned reports

* Project Lead for Travel Time Study managing a team of six engineers and finalized data to post accurate travel times alongside major highways to all Dynamic Messaging Systems

* Assisted in the implementation of the Express Lanes Module Test Plan and made comments and suggestions to the Test Plan before finalizing the approval

* Validated G4 Detector data on I-95

* Verified all checks and balances for invoices on various Florida Highway Patrol Contract

* Utilized Contract Management System to ensure proper asset allocation for various projects including Travel Time Studies, SunGuide Mobile, Travel Time Field Comparison Software Etc.

* Added Travel Time links, detector links, and detector link lengths to SunGuide Production

* Worked with HNTB and Transcore to implement Loop Detectors, In Pavement Sensors, or MVDS Sensors on I-95 by performing field site surveys

* Mapped detector links in SunGuide Production

* Re-Structured ITS Maps to consistently match present conditions on the roadway

January 2009-October 2010 Florida International University

Research Assistant Miami, FL

* Researched electrical properties of blood such as resistance, impedance, capacitance, conductance, resistivity and dielectric constant to correlate their behavioral properties to pathological diseases

* Proposed a novel biomedical screening device utilized to advance disease detection at an earlier state by correlating measured impedance values to various pathologies.

* Explored various experimental methods including dielectric spectroscopy, dielectric waveguide measurement system, conductivity method, electrical measurement of blood coagulation, in vivo determination of blood properties via catheterization, and finger plethysmography utilized to analyze the difference and similarities among several electrical properties of blood

EDUCATION

Florida International University, Miami FL

Bachelor of Science in Biomedical Engineering

LICENSURES

State of Florida

License # P229847

Legal Expense

Life and Variable Annuity

Contact this candidate