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Work Background
O&M HalyardQuality Engineer
Mar. 2016 - Oct. 2018Tucson, Arizona• Reduced customer complaints for missing components on kits by elaborating and implementing an engineering study to get reliable results when counting raw material on scales to send the exact amount needed to production. • Investigated Quality Non-conformances (QNC) and Customer Complaints to identify root causes and implement preventive and corrective actions to eliminate reoccurrences and potential failures. • Elaborated and executed Installation Qualification (IQ) protocol and report for Laser Stripping Station. • Elaborated and executed Test Method Validations (TMV) protocols and reports. • Involved in several process validations (IQ, OQ, PQ and TMV) • Project leader of global and local Change Controls for implementing changes on processes or products. • Performed internal audits to review compliance of Doc. Control procedures, as part of CAPA effectiveness verification. • In charge of reviewing and approving new documents and revisions. • Created Process FMEA’s and coordinated with Technical Quality to determine severities for each failure mode. • In charge of maintaining all Device Master Records and the Master Validation Plan up to date. • Retrieve QNC data and presented its metrics on Management Review quarterly meetings.
Tangent Medical TechnologiesManufacturing Engineer
Nov. 2012 - Jun. 2014Hermosillo Mexico● Increased production from 800 to 2000 IV catheters per shift. Performed a time study analysis on every station and redesigned production line by reducing number of operators and adding stations in bottleneck. ● Kept record of all scrapped material. Proposed and created an excel file that calculates components from every subassembly depending on the station they were scrapped. ● Effectively trained operators in catheter cut, glue and quality testing stations before production started. ● Defined Min and Max setup limits for Catheter glue station after performing a DOE process (Design Of Experiments). ● Performed inspection and approbation of 80% of the incoming material for production use. ● Elaborated and executed Installation Qualification (IQ) for catheter cutting station. ● Improved operators safety by designing in AutoCAD a needle fixture that made needle handling safer and easier.
Lanix Med GlobalEngineering Intern
Oct. 2012 - Nov. 2012Hermosillo MexicoTangent's production line is located at Lanix Med Global facility. I started working as an intern in Lanix and Tangent made me a job offer 1 month later. These were my duties as an Engineering Intern: ● In charge of Preventive Maintenance (PM) for all equipment in Tangent’s production line. ● Improved scrap accounting by creating a paper format to keep record of each scrapped part from each station. ● Collaborated organizing inventory in warehouse. ● Assisted writing Installation Qualification (IQ) for Oven machine.
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