Experience

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  Storage technology of puerto rico

  Sept 1998 - Dec 2002

  Supplier quality engineer

  •Apply standard engineering techniques, procedure, and criteria after evaluation and selection during the execution of engineering tasks, using judgment in support of engineering functions.•Investigate incidents reports and resolved them with clear and specific objectives to scrutinize a number of variables to accomplish the quality and reliability of the product as well the client satisfaction.•Analysis of situations or data of problems of moderate scope that requires a review of identifiable factors; judging within defined procedures and practices to determine appropriate corrective and preventive action. Show less

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  Medtronic

  Jan 2003 - now

  Accomplishments: •Reduced escapes by 25% by leading projects and implementing actions to reduce the source of defects and to increase detectability. •Increase yields by 4% (in average) by leading teams that implemented actions focused in the reduction of scrap and risk associated to process defects. •Lead new product transfers (assembly to final packaging) from a quality perspective ensuring all qualifications and validations of product /equipment and processes are completed on time while meeting operational objectives.•Lead/conduct First Time Quality (FTQ) initiative at vertical supplier (SLK facility) to improve product quality and determine action plan before transfer process to an external supplier. Responsibilities:•Lead investigations and develop action plans that will mitigate issues in the operations, caused by personnel, equipment or suppliers. •Assure that processes comply with specifications, Quality Systems Regulations and ISO standards.•Evaluation of the implemented corrective and preventive actions to assess effectiveness of it.•Writes procedures, protocols and any other documentation needed for the enhancement of systems.•Assists and supports regulatory/internal inspections, such as (TUV, FDA, MCare).•Supervise a staff of 3 technicians/inspectors responsible for the prompt identification of sources of defects or potential issues. •Participated and co-lead a team of 5 persons as part of the Risk Management Quality Improvement Plan.•Lead RTG Villalba FTQ initiatives and part of MVC FTQ coaches.•Lead manufacturing operations project initiatives (High risks PODs update, UDI implementation, COS PFMEA conversion, qualification activities for COS line conversion, First Article Inspections (FAI), Villalba Neuromodulation focal point for investigations with Business sector).•Delegate of Quality Systems Manager. Show less •Support 500 level and sterile pack/sterilization/final pack manufacturing lines and actively participated in the qualifications and validations of product /equipment and processes. •Support new product transfers (500 level and sterile/final packaging) and actively participated in the qualifications and validations of product /equipment and processes. •Lead Prostiva product transfer from MPROC Villalba Neuromodulation to Medtech (contractor) at Vega Baja. •Implement engineering change order and maintain manufacturing/inspection procedures.•Evaluate product/material with nonconformities including MRB/PRB, Design and Manufacturing Deviations, Product Hold Order, Non Conformance Report, CAPA, Product Comment Report.•Conduct failure investigations and issue written reports in order to initiative, stimulate and assign root cause and corrective action. •Assure that processes comply with specifications, Quality Systems Regulations and ISO standards.•Evaluation of the implemented corrective and preventive actions to assess effectiveness of it.•Writes procedures, protocols and any other documentation needed for the enhancement of systems.•Assists and supports regulatory inspections, such as (TUV, FDA).•Supervise a staff of 3 quality technicians.•Participate and co-lead a team of 4 persons as part of the Statistical Techniques Quality Improvement Plan (Sep 11-Jan 13). Show less •Support 500 level manufacturing lines and actively participated in the qualifications and validations of product /equipment and processes. •Implement engineering change order and maintain manufacturing/inspection procedures.•Evaluate product/material with nonconformities including MRB/PRB, Design and Manufacturing Deviations, Product Hold Order, Non Conformance Report, CAPA, Product Comment Report.•Conduct failure investigations and issue written reports in order to initiative, stimulate and assign root cause and corrective action. •Assure that processes comply with specifications, Quality Systems Regulations and ISO standards.•Support Factoryworks implementation at Final pack area. Show less

  • Sr. Quality Systems Program Manager

    Jul 2022 - now

  • Quality System Manager

    Nov 2016 - Jul 2022

  • Principal Quality Engineer

    Jun 2012 - Nov 2016

  • Sr. Quality Assurance Engineer

    Mar 2006 - Jun 2012

  • Quality Assurance Engineer

    Jan 2003 - Mar 2006