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OMAR ALVARADO
2158 Prairie View Ct • Menasha WI 54952 • Phone: (920) 815-3440
Email: trunx32@hotmail.com
PROFESSIONAL OBJECTIVE
 A Quality Engineer position providing the opportunity to make a strong contribution to organizational goals through
professional experience and outstanding personal skills.
ENGINEERING PROFILE
 Engineering work experience in a high-tech manufacturing environment producing medical devices regulated by the FDA.
 Experience with the design installation and improvement of quality management systems integrating people, technology,
materials, and information.
EDUCATION
 University of Texas at El Paso
Bachelor of Science Degree – Industrial Engineering – May 2006
WORK EXPERIENCE
Quality Engineer March 2010-Present
Plexus – Neenah, WI
 Responsible for being the key contact between manufacturing and the customer related to manufacturing and quality
processes.
 Responsible for the overall customer quality and regulatory requirements are met and product meets all specifications.
 Facilitate resolution of proactive quality initiatives through preventative actions and mistake-proofing.
 Facilitate resolution of reactive quality initiatives through containment/root cause/corrective actions.
 Responsible for creating and presenting quality metrics such as Yields, DPMO, and DPPM.
 Train cross-functional teams in quality systems (ISO 13485/ISO 9001), tools, and 21CFR820 regulations.
 Create customer quality plans, and responsible for the quality activities related to new product introductions.
 Approve product changes (ECOs, deviations, validation reports) to ensure customer and regulatory requirements are met.
 Review quote and contracts to ensure customer quality requirements are met.
 Attend Material Review Board meetings to determine dispositioned of rejected product or materials.
 Coordinate continuous improvement team meetings to drive high product quality and increase customer satisfaction.
 Responsible for quality planning, inspections, efficiency improvements, waste reductions, material substitutions, and other
quality related functions within manufacturing operations.
 Support Part Quality Plan (PQP) activities, and created PFMEA and Control Plans.
 Implement FMD DMR, DHR, Product Release, and customer complaint process.
 Responsible for monitoring and controlling an ISO 14644-1 Class 8 Cleanroom.
 Support internal layered process audits.
Quality Assurance Engineer August 2006-January 2010
Wistron – El Paso, TX
 Lead quality teams (IE, ME, PE, and PD) in driving high product quality, continuous improvement, and increase customer
satisfaction.
 Apply statistical Control using tools such as SPC, control charts, CpK, Gage R&R, paretto charts, histograms, FPYR and
DPPM, & DPMO.
 Use problem solving techniques such as PFMEA, 8D’s, 5 Why’s, CAR, cause and effect diagrams, process flow charts,
DMAIC.
 IPC-610 Trainer for PCB Inspectors and Repair Technicians.
CERTIFICATIONS
 Six Sigma Green Belt, IPC-A-610 Specialist (CIS), and ISO 9001 Internal Auditor.
COMPUTER/EQUIPMENT SKILLS
 Microsoft Office, Agile, Minitab, JD Edwards, TipQA, MAX, Microscope, X-ray, Particle Counter, and Caliper.
PERSONAL/PROFESSIONAL SKILLS
 Extensive working knowledge of quality systems (ISO 13485/ISO 9001), Lean, and Six Sigma.
 Proficient working knowledge of FDA (21CFR820) regulations for the manufacturing of medical devices.
 Ability to lead and multi-task in a dynamic environment.
 Bilingual (Spanish & English), excellent learning curve, excellent communication skills, self-management capabilities,
team player, and leadership.

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Omar Alvarado Resume (07FEB2017)

  • 1. OMAR ALVARADO 2158 Prairie View Ct • Menasha WI 54952 • Phone: (920) 815-3440 Email: trunx32@hotmail.com PROFESSIONAL OBJECTIVE  A Quality Engineer position providing the opportunity to make a strong contribution to organizational goals through professional experience and outstanding personal skills. ENGINEERING PROFILE  Engineering work experience in a high-tech manufacturing environment producing medical devices regulated by the FDA.  Experience with the design installation and improvement of quality management systems integrating people, technology, materials, and information. EDUCATION  University of Texas at El Paso Bachelor of Science Degree – Industrial Engineering – May 2006 WORK EXPERIENCE Quality Engineer March 2010-Present Plexus – Neenah, WI  Responsible for being the key contact between manufacturing and the customer related to manufacturing and quality processes.  Responsible for the overall customer quality and regulatory requirements are met and product meets all specifications.  Facilitate resolution of proactive quality initiatives through preventative actions and mistake-proofing.  Facilitate resolution of reactive quality initiatives through containment/root cause/corrective actions.  Responsible for creating and presenting quality metrics such as Yields, DPMO, and DPPM.  Train cross-functional teams in quality systems (ISO 13485/ISO 9001), tools, and 21CFR820 regulations.  Create customer quality plans, and responsible for the quality activities related to new product introductions.  Approve product changes (ECOs, deviations, validation reports) to ensure customer and regulatory requirements are met.  Review quote and contracts to ensure customer quality requirements are met.  Attend Material Review Board meetings to determine dispositioned of rejected product or materials.  Coordinate continuous improvement team meetings to drive high product quality and increase customer satisfaction.  Responsible for quality planning, inspections, efficiency improvements, waste reductions, material substitutions, and other quality related functions within manufacturing operations.  Support Part Quality Plan (PQP) activities, and created PFMEA and Control Plans.  Implement FMD DMR, DHR, Product Release, and customer complaint process.  Responsible for monitoring and controlling an ISO 14644-1 Class 8 Cleanroom.  Support internal layered process audits. Quality Assurance Engineer August 2006-January 2010 Wistron – El Paso, TX  Lead quality teams (IE, ME, PE, and PD) in driving high product quality, continuous improvement, and increase customer satisfaction.  Apply statistical Control using tools such as SPC, control charts, CpK, Gage R&R, paretto charts, histograms, FPYR and DPPM, & DPMO.  Use problem solving techniques such as PFMEA, 8D’s, 5 Why’s, CAR, cause and effect diagrams, process flow charts, DMAIC.  IPC-610 Trainer for PCB Inspectors and Repair Technicians. CERTIFICATIONS  Six Sigma Green Belt, IPC-A-610 Specialist (CIS), and ISO 9001 Internal Auditor. COMPUTER/EQUIPMENT SKILLS  Microsoft Office, Agile, Minitab, JD Edwards, TipQA, MAX, Microscope, X-ray, Particle Counter, and Caliper. PERSONAL/PROFESSIONAL SKILLS  Extensive working knowledge of quality systems (ISO 13485/ISO 9001), Lean, and Six Sigma.  Proficient working knowledge of FDA (21CFR820) regulations for the manufacturing of medical devices.  Ability to lead and multi-task in a dynamic environment.
  • 2.  Bilingual (Spanish & English), excellent learning curve, excellent communication skills, self-management capabilities, team player, and leadership.