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.