Cell: 915-***-****

bkkyix@r.postjobfree.com

Felipe Loya

Education:

California State University, Sacramento

* Masters in Business Administration

University of Texas at El Paso

* Bachelor of Science in Electrical Engineering

Languages & Certifications

* Fluent in reading, writing, and speaking Spanish.

* ASQ Certified Quality Manager CQM/Operational Excellence, CQA

* PMI Project Manager Professional (PMP)

* Six Sigma Green Belt Certified

Experience:

April, 2010 – December, 2011 CareFusion, Inc. El Paso, TX

Manager, Program Manager, R&D - Infection Prevention Business Unit

*Responsible for overall new product development execution and timeline generation.

*Working knowledge of 21 CFR 210, 211, 820, 510(k) application process for medical devices, Design Control and new product development life cycle.

*Able to facilitate cross functional team interaction to identify all project risks, develop mitigation plans and work to have strategies in place to resolve identified issues.

* Collaborate with project team members to define scope and project requirements.

* Managed project costing, resource planning and budget.

* Defined roles and responsibilities for each group to improve company processes and strengthen communication channels.

*Responsible for the development of a combo (Pharmaceutical –medical device) product (antimicrobial catheter dressing) representing a forecast revenue of $34 million in 5 years.

2006 – 2010 Johnson & Johnson, Inc.

Sr. Design Quality Engineer – Ethicon, Inc. Somerville, NJ

*Support design control activities for new and change product development efforts.

*Ensure effective and comprehensive quality strategies for design development, verification & validation, and regulatory requirements.

* Provide quality-engineering support in resolving supplier-related quality issues.

*Work thorough investigation of quality issues and effective corrective and/or preventive action.

*Provide guidance to project teams and other disciplines to ensure compliance with company policies and procedures, as well as medical device regulations such as FDA 21 CFR 820, and ISO 13485.

*Responsible to develop, conduct, and document qualifications/validations to ensure that the products processed are proven to be reliable, safe, and effective prior to product release.

Global Pharmaceutical Supply Group - Vacaville, CA

Sr. Engineer – Technical Project Leader for New Product Launch

* Acted as Technical project leader in projects involving the qualifications of electronic, electro-mechanical and plastic components.

* Served as a liaison for technical process issues between suppliers and the Quality, Manufacturing, and Engineering departments.

* Responsible for drafting, approval and execution of product verification and validation protocols (IQ, OQ, PQ and URS) as necessary.

• Working knowledge of FDA QSR, 21 CFR 210, 211, 820, and ISO 9000:2000.

2004 – 2006 SOLECTRON Austin, TX

Supplier Quality Engineer

* Provide factory support to identify and resolve issues associated with purchased parts, materials and manufacturing.

* Responsible for fiber optics, power supply, and connection systems commodities.

* Performed Supplier processes audit for main manufacturing areas, such as ESD, PCB handling practices, documentation, training and process integrity.

2003 - 2003 Yazaki NA - Elcom El Paso, TX

Supplier Quality Engineer

* Control Suppliers quality rating and quality improvements targets.

* Setup/Lead QIP meetings with Suppliers

* Perform New supplier assessment, Supplier Quality system audits and Control Plan walk through.

* Responsible for analysis of supplier's PPAPs, 8D reports, Control Plans, FMEAs, SPC, etc.

* Responsible for supplier RMAs, sort, scrap, debits/credits and quarantine cage management.

1997 - 2002 Philips Electronics - Monitors Juarez, MX

Sr. Supplier Quality Engineer

* Oversee and maintain the Philips Supplier Management Quality program.

* Support product release through Supplier quality management tools (FAI, FMEAs, Control Plans, SPC, etc.).

* Continuously work with Suppliers in improvement plans related with Supplier's process.

* Monitor Suppliers Quality trend and perform regular Quality system audits based on ISO-9000 and Philips requirements.

* Responsible for Plastic, Metal stamping, Packaging, CRT and Chassis commodities.

* Responsible to perform MRB meetings to all non-conforming materials.

Electrical Product Engineer

* Analysis and solution to technical problems related to computer monitors production.

* Production line technical support.

* Responsible for the implementation of Engineering changes, BOM validation, FNs, CPs, and ECN.

* Introduction and transfer of new projects.

Programming, Electrical Engineering and other Skills

* Able to program in C++, Java, 80C51 assembly, XML, XPath, HTML, PHP, MySQL and LABVIEW.

* Familiar in the use of software titles: Microsoft Word, Excel, Access, Visio, MS Project, MatLab, Primavera and Minitab.

* Familiar with the use of oscilloscope, digital multi-meter, HP spectrum analyzer, HP logic analyzer and curve tracer.

*Knowledge in Statistics: t-test, ANOVA, Design of Experiments, Chi-squared test, Correlation, Factor Analysis, Regression Analysis, etc.

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