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Sr Consultant Applications Design and Development Resume Example

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SR CONSULTANT APPLICATIONS DESIGN AND DEVELOPMENT
Summary

Hands-on motivated Leader with an Engineering degree and 21 years of experience in the manufacturing industry. In depth experience in Quality Assurance successfully developing, implementing and monitoring Quality Systems to ensure quality products and conformance to requirements. I have developed Quality Systems from scratch, and successfully implemented them to meet ISO 9001, ISO13485, MDD, GE Healthcare QMR policies, FDA regulations and specific industry standards.


I recently obtained my PMP Certification from PMI. My extensive Project management experience includes QA, Commercial and IT projects.

I am a certified Internal Auditor (BSI) and I have been the Management Representative of the Quality System for 4 of the companies I have worked for. I have extensive experience planning, coordinating, conducting and hosting Internal Audits, FDA Inspections, Customer Audits, Vendor Audits and third party registrar audits.


Highlights
  • Project Management
  • Quality Systems / Quality Assurance / Quality Control
  • Auditing
  • Process / Systems Integration
  • EDI
  • Data Conversion
  • Root Cause Analysis
  • Training
  • Oracle / SAP / HPQC /
Accomplishments
  • Successfully led 2 FDA site Inspections with satisfactory results: Zero major 483's
  • Successfully implemented the Quality System and achieved the ISO9002 and ISO9001 certification with zero non-conformances at 3 of the facilities I worked for. Two of these Projects were achieved 4 months and 1 month before target date.
  • Implemented a non-destructive, in-process leak test for a dyalisis product line that reduced scrap cost by $230,000.00 a year
  • Nominated great talent to attend the 2010 and 2012 GE Hispanic forum summit
  • Recipient of 2 GE Hero Awards and 1 GEHC President's Award

Experience
Sr Consultant Applications Design and Development
June 2014 to CurrentCarefusion － San Diego, CA
  • Customer Master and Pricing Data conversion from Oracle to SAP. Responsible to extract, cleansed, standardize and prepare data prior to conversion
  • Sales data conversion from Cognos to OASIS. Responsible to lead a team of external contractors to install daily feeds of Production sales data and extraction, cleansing and standardization of historical data.
  • Variable compensation sales data validation. Worked with Finance and Sales Operations Leaders to execute 2 validations of VC data. Executed Analysis and rework of data to apply correct compensation to Sales team members.
  • Executed testing in HPQC for both Carefusion and GE projects during the transition from Oracle to SAP.
  • Developed and implemented daily SAP reports for Sales teams
Manager Global Commercial Processes / Site Quality Leader / Acting QARA Director
April 2010 to June 2014GE Healthcare － Totowa, NJ
  • Manager, Global Commercial Processes:
  • Project Leader for Customer Master and Pricing data conversion from JDE-Oracle
  • Project Manager for EDI conversion from JDE-Oracle and from Inovis-GHX.
  • Project Manager for GFAX implementation.
  • Developed/implemented processes aimed to improve "easiness to do Buisness with GEHC VS. As project Manager of the "Customer Experience Enhancement Project" I developed/implemented processes to improve fulfillment/Customer Service team expertise/Customer Service Levels/Sales Team effectiveness. I worked closely with Customer facing Teams and IT to develop solutions and automate processes to effectively monitor/improve customer experience.
  • SQL / Acting QARA Director:
  • Represented the site in the FDA Inspection with successful results of zero major 483's
  • Management representative for site, responsible to coordinate external audits and FDA inspections.
  • Developed intra-sites internal audit program between Colorado and Totowa.Implemented internal audit program at site: Conducted off-site training and qualified a team of 10 Auditors.
  • Lead quarterly Management Reviews for site
  • Project manager for GEHC QMS integration at site.
  • Implemented Final Product Release process at site to ensure compliance. Qualified and transfered 4 employees from operations to QA to achieve implementation.
  • Responsible to develop goals for QA/QC and RA for both Totowa and Colorado.
  • Ensure metrics for both Totowa and Colorado are complete on time. Establish operating mechanisms to ensure we meet metrics for sites.
  • Identify gaps/opportunities through the complaints and CAPA handling/trending mechanisms to ensure compliance/ efficiency.
QA Engineer / Acting Site Quality Leader
January 2008 to April 2010GE Healthcare － Laurel, MD
  • Represented the site during the FDA inspection. Resulted in zero 483s
  • Project manager for Integration of GE Healthcare global QMS. Leading cross-functional team of 8 professionals in 6 different departments to implement GEHC policies and procedures
  • Led the quarterly site Quality Management Reviews
  • Coordinated the annual QMS BSI audit
  • Processes that I have implemented or revised at my site include: Final Product release, DHR, Rework and reconfigurations, Product Hold, internal audit, out of tolerance (calibration), and control of shelf life
  • Initiatives I have led:
  • Internal Lead Auditor responsible for the execution of the internal audit program. Prepare annual internal audit schedule, train/qualify internal audit team, coordinate audit execution, assign tasks to auditors, prepare audit plan and report, create CAPAs for every NC from audits and verify effectiveness prior to closure
  • Site coordinator for Product Hold.
  • Project Manager to implement Final Product Release process. Process owner for execution of final release, closure of discrepancies, and confirmation of complete reports for records reviewed/rejected
  • Support Manufacturing department by providing approvals and guidance on: validation and verification protocols, out of tolerance tools disposition, maintenance and calibration procedures, manufacturing procedures and work instructions, reworks, first article inspections, returned goods dispositions, translation validations, ECR, ECO, discrepant material reports, concessions, data
QA Manager
September 2003 to December 2007ARLON ECP － San Antonio / Dallas, TX
  • Implemented the Quality Management system from scratch, achieving the ISO9001:2000 certification in San Antonio TX on a 5 months period and in Dallas TX facility in 8 months. Unique QMS implemented to comply with ISO9001, ISO13485 and QS9000 (ISO/TS 16949) due to the variety of Customers in the companie's portfolio.
  • Start-up company transfered from Rhode Island to Texas. I screened and recruited all the personel in the QA department which included Chemists, Biologists and Technicians.
  • Implemented and lead the internal audit program which consisted of coordinating audits for three facilities: San Antonio and Dallas TX, and Santa Ana California, and assigning tasks to a team of 10 Auditors
  • Coordinated and executed all Supplier audits with support from Design and Purchasing departments.
  • Management Representative of the QMS
  • Prepared and executed all semi-annual Quality Management Reviews
  • Coordinated and hosted all external audits (Customer, BSI, UL, CSA)
  • Responsible for CAPA, NC product, complaints, Product HOLD, training, document control, all Quality Control activities including incoming, in-process and final inspections and
  • tests.
  • Successfully completed PPAP's with all the elements required for the qualification of an Automotive Industry Customer product.
  • Reduced the “Expired” inventory from $280,000.00 to $29,000.00 in a 4 months period. About 80% of the materials were salvaged through re-qualification and re-work
  • Project Leader of the Lean Manufacturing implementation team. On charge of standardize work and TPM's for all the kaizen events in the company
  • Implementing and leading continuous improvement teams, which evaluates ideas from all employees and made final decisions on implementation: PIE (Performance is for everyone) teams and Kaizen teams
QA Manager
March 2001 to November 2002DelStar Technologies － Austin, TX
  • Implemented the QMS from scratch
  • Project Leader for project to re-model a manufacturing area that will meet Class II medical devices environments. Company not a registered FDA site, however a direct supplier to medical device companies, required to meet ISO13485 and GMP guidelines.
  • Implemented the internal audit program. Coordinated the qualification of the Auditors team and the execution of all internal audits.
  • Responsible for training, CAPA, Non-conforming product, complaints, document control and Product HOLD, QC activities: incoming, in-process and final inspection and tests.
Quality Assurance Director
March 1999 to January 2001Pharmacare LTD － Ramallah, West Bank / Palestine
  • Developed the QMS to comply with GMP and ISO13485. Middle Eastern company trying to achieve registration to sell products in USA and Europe.
  • Trained and qualified team of 20 Internal Auditors.
  • Implemented the internal audit program, which consisted of bi-monthly audits in two sites.
  • Instrumental on helping the business sign a joint venture with German pharmaceutical company after implementing QMS.
  • Responsible for validation and verification, document controls, training, Product HOLD, NC product, CAPA and complaints.
  • Responsible for all QC activities including incoming, in-process and final inspections and tests
Quality Manager - Production Manager
September 1995 to December 1998Peerless Industries de Mexico － Monterrey, Mexico
  • Successfully implemented the Quality System and achieved the ISO9002:1994 certification with zero non-conformances
  • Management Representative of the QMS
  • Coordinated and executed quarterly Management Reviews
  • Implemented internal Audit program which consisted of a team of 4 Auditors and one site
  • Responsible for CAPA, complaints, training, document control, NC product, continuous improvement team
  • Responsible for all QC activities including incoming, in-process and final inspections and tests
  • As a Production Manager responsible for scrap reduction, distribution, shipping and production
  • Reduced scrap levels from 800 to 250 pounds of metal per week.
  • Increased production efficiency up to 23%
Quality Engineer
January 1994 to September 1995National Medical Care － Reynosa , Mexico
  • Implemented a non-destructive, in-process leak test for a dyalisis products line that reduced scrap cost by $230,000.00 a year
  • Executed all validations in the Master Validation Plan.
Quality Supervisor
January 1993 to January 1994Meditron － Reynosa, Mexico
  • Transfered the QMS from site in NY USA, to Reynosa Mexico
  • Responsible for Quality Control activities including incoming, in-process and final inspection and tests.
  • Responsible for final product release process
  • Responsible for the labeling area which included printing labels, issuing and reconciling returned labels, approving contents and approving molds for printers.
  • Trending of Non-conformances to implement corrective actions and preventive actions
  • Investigation of Customer complaints
Education
Bachelor of Science : Computer Engineering, 2002Universidad Autónoma de Nuevo Leon － Monterrey, NL, Mexico

Computer Engineering

Associate of Arts : English, 2002Universidad Autonoma de Nuevo Leon － Monterrey, NL, Mexico
Personal Information
Additional Information
  • My industry experience includes pharmaceutical, medical devices, metal stamping, plastics extrusion and molding, coating and laminating and assembly lines. I have worked for companies in three different countries which gives me the experience to work in multicultural environments.
  • I am bilingual English-Spanish and I have basic communication skills in Arabic
Skills
  • PMP certified
  • ISO9000 / ISO13485
  • Internal Auditor certified
  • FDA
  • EDI / GFAX / ORACLE / SAP
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Resume Overview

Companies Worked For:

  • Carefusion
  • GE Healthcare
  • ARLON ECP
  • DelStar Technologies
  • Pharmacare LTD
  • Peerless Industries de Mexico
  • National Medical Care
  • Meditron

School Attended

  • Universidad Autónoma de Nuevo Leon
  • Universidad Autonoma de Nuevo Leon

Job Titles Held:

  • Sr Consultant Applications Design and Development
  • Manager Global Commercial Processes / Site Quality Leader / Acting QARA Director
  • QA Engineer / Acting Site Quality Leader
  • QA Manager
  • Quality Assurance Director
  • Quality Manager - Production Manager
  • Quality Engineer
  • Quality Supervisor

Degrees

  • Bachelor of Science : Computer Engineering , 2002
    Associate of Arts : English , 2002

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