, San Francisco, CA94105(555) 432-1000, resumesample@example.com
Professional Summary
Quality Engineer with 3 years of experience in the Medical Devices industry
eager to contribute to team success through hard work, diligence, and excellent
organizational skills. Adept at performing quality inspections and identifying
root causes for non‐conforming material issues. Hardworking and meticulous
with a passion for continuous improvement.
Skills
Non‐Conforming Material Reports
NCMR
Root Cause Analysis
Product development, Design Control
Statistical Process Control SPC
Quality Improvement Plans
Process Change Documentation
Geometric Dimensioning and
Tolerancing GD&T
Quality Management
Continuous Improvement
Streamline
AutoCAD
CAD
Continuous Improvement
Product development
Documentation
ERP
IQ
Materials
OQ
Personnel
PQ
Processes
Proposals
Purchasing
Quality
Quality assurance
Quality Control
Quality Management
Quality Improvement
Receiving
Risk Management
SPC
Statistical Process Control
Validation
Work History
06/2019 to CurrentQuality EngineerBank Of America Corporation | Lorton, VA,
Develop, review, and approve Design Transfer/Manufacturing Transfer Plans.
Support training and certification of incoming inspectors.
Develop Attribute & Variable Data Test Method Validations and conduct Gage R&R
Studies.
Review and approve Quality Risk Assessments, First Article Inspections, Component
Qualification Plans, and Reports to assure components, materials and suppliers
meet specified requirements.
Drive supplier development program to reduce receiving inspection and prevent
products related rejections in manufacturing and field.
Evaluate and disposition Non‐Conformances and drive risk‐based Corrective
Actions to prevent recurrence.
Assist with Suppliers Change requests SCRs and PPAPs.
Streamline inspection processes by reducing additional handling and labor cost.
Lead and implemented SOQ program and exceeded organization's cost savings
goals for Fiscal Year 20 by 180%.
Implement new Quality Agreements for critical suppliers to confirm agreements for
quality compliances and business requirements between suppliers.
Develop Quality Control Plans, control characteristics, and Validation Plans.
Prepare Gage sheet and Inspection criteria sheet for newly created test methods.
Assist Quality Engineering management to implement and develop process and
product improvements.
01/2018 to 06/2019Mechanical EngineerPlug Power Inc. | Hagerstown, MD,
Prepare preliminary and detailed engineering drawings to customer
requirements using AutoCAD and Inventor.
Study specifications, engineering drawings, tool orders, shop data and
conferred with engineering and shop personnel to resolve design problems
related to material characteristics, dimensional tolerances, manufacturing
procedures, and cost.
Work and lead communications with customers, quality assurance team,
purchasing vendors, and suppliers.
Maintain detailed records in ERP system.
Assist quality assurance in IQ, OQ & PQ activities, and Validation process.
Support Risk Management activities.
Review and check technical drawings by CAD technicians and drafters.
Review project goals and objectives on monthly basis with project manager
and design team.
Prepare cost estimates, schedules, and project specifications for proposals.
Education
Expected in 2018Master of Science | Mechanical
EngineeringCalifornia State University, Fullerton, CAGPA: GPA: 3.5
Expected in 2014Bachelor of Science | Aeronautical
EngineeringMalla Reddy College of Engineering, , GPA: GPA: 3.0
Work History
06/2019 to CurrentQuality EngineerMedtronic Warsaw Orthopedics | Warsaw, IN
Develop, review, and approve Design Transfer/Manufacturing Transfer Plans.
Support training and certification of incoming inspectors.
Develop Attribute & Variable Data Test Method Validations and conduct Gage R&R
Studies.
Review and approve Quality Risk Assessments, First Article Inspections, Component
Qualification Plans, and Reports to assure components, materials and suppliers
meet specified requirements.
Drive supplier development program to reduce receiving inspection and prevent
products related rejections in manufacturing and field.
Evaluate and disposition Non‐Conformances and drive risk‐based Corrective
Actions to prevent recurrence.
Assist with Suppliers Change requests SCRs and PPAPs.
Streamline inspection processes by reducing additional handling and labor cost.
Lead and implemented SOQ program and exceeded organization's cost savings
goals for Fiscal Year 20 by 180%.
Implement new Quality Agreements for critical suppliers to confirm agreements for
quality compliances and business requirements between suppliers.
Develop Quality Control Plans, control characteristics, and Validation Plans.
Prepare Gage sheet and Inspection criteria sheet for newly created test methods.
Assist Quality Engineering management to implement and develop process and
product improvements.
01/2018 to 06/2019Mechanical EngineerAmerican National Manufacturing inc | Corona, CA
Prepare preliminary and detailed engineering drawings to customer
requirements using AutoCAD and Inventor.
Study specifications, engineering drawings, tool orders, shop data and
conferred with engineering and shop personnel to resolve design problems
related to material characteristics, dimensional tolerances, manufacturing
procedures, and cost.
Work and lead communications with customers, quality assurance team,
purchasing vendors, and suppliers.
Maintain detailed records in ERP system.
Assist quality assurance in IQ, OQ & PQ activities, and Validation process.
Support Risk Management activities.
Review and check technical drawings by CAD technicians and drafters.
Review project goals and objectives on monthly basis with project manager
and design team.
Prepare cost estimates, schedules, and project specifications for proposals.
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