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Quality Engineer

Location:
Encino, CA
Posted:
March 05, 2019

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Resume:

Contact info: 323-***-**** Email: ac8oo6@r.postjobfree.com City: Lake Balboa, CA 91406

Professional Summary:

Determine the most effective ways to conduct the product realization through the monitoring, the design and the creation of quality systems to ensure and control the different processes involved in the production, based on the applicable ISO; considering people, machines, materials, information (metrics, KPI’s) energy and technology.

Experience:

Wabtec Position: Quality engineer (from Aug 2018 - present).

Responsible for Management Responsibilities (Management Review, Quality Objectives, Quality policy), Quality Engineering, Design Quality Assurance, Quality Systems, Supplier Quality, Complaint Management, Incoming and shipping, Document Control, Nonconforming Materials.

Achievements:

Automatic system for incoming inspection for traceability of components was designed.

Developed and analyzed statistical data and product specifications to determine present standards and establish proposed quality and reliability expectancy of finished products. Planned, developed and maintained all standard operation procedures to fulfill the ISO requirements.

Designed and implemented process level audit program for final and in process.

Spark of hope (nonprofit organization) manufacturing of Prosthetics (December 16 to June 2018).

Create and design programs for the control and execution of projects.

Design the non profit software.

Achievements:

Conceived and launched fundamental values and ethical principles.

Evaluated and designed machine tooling to produce the parts in the most successful way.

PHASE 2 (Medical devices). Position: Quality Assurance Specialist (Supervisor) (Oct 2015 – Dec 16).

Provide guidance on ISO & QSR requirements as part of the QA support to new product developments.

Responsible for the process quality assurance, statistical process control, calibration I non-conforming materials, product lot release testing, and finished goods control and quality systems / Design and evaluation of system analysis.

Managing the implementation of the Quality Management System (QMS) and quality systems.

Overall Supplier Quality control activities.

Built working partnerships with suppliers to ensure product quality and improved score card performance

Prepare Engineering Change Orders (ECOs) and supporting documentation to effectively control new product.

Achievements:

Successfully conducted audit of ISO 13485 as responsible of the quality system.

Cost reduction for more than 30 K in materials.

Successfully created and quality training for all operations personnel in compliance with process instructions.

Designed and implemented company audit/ process program.

Developed revenue cycle to align strategic and financial goals and present to department of managers.

Collaborated with senior management on Business Process Reengineering, gaining 20% increase in productivity and reducing quality 30% of rejection.

MIURA CORP (research and Development Company). Position: Quality assessor (From January 2014 to October 2015).

Responsible of the design and implementation of the quality system ISO 9001:2008

Achievements:

Coordination of personnel for the creation ISO system and software.

MUTSUTECH (Automotive and injection molding). Position: Quality supervisor (From January 13- December 13).

Responsible for the quality and inspection departments (internal audit, process, incoming) and dimensional room.

Implement the Advance Product Quality Planning, Calibration systems and Supplier Development systems.

Achievements:

Maintained the ISO 16949 registration.

Cost reduction above 15,000 dlls in month (Reducing NG, extra time by organizing the manpower).

Prepared PPAP documents; Control Plan, Flow Charts, Process Drawings, PSW's and PFMEA's Designed software to track correct and preventive/corrective actions.

MARTECH Medical Products. QA & QC supervisor (Aug 11 – Aug 12).

Develop and initiate standards and methods for operation, inspection, testing, and evaluation.

CAPA resolution: identify root causes of non-compliance and ensure timely/effective corrections and /or corrective preventative actions are implemented.

Validation and qualification activities: Prepares, executes, and finalizes requirements and design specifications and protocols (IQ, OQ, PQ).

Achievements:

Implementation of GR&R, MSA (measurement system analysis) and capacity program plan in 3 plants.

MPA Motorcar Parts of America (Automotive Company). Position: Quality Supervisor, Time Labored: Sep 09- Aug 11

CAPA’s resolution (reduced past due CAR’s)

Keeping PFMEA's current to process, creation of flow charts, Lead PPAP and APQP.

Achievements:

Cost saving program implemented. (Improvement in torque equipment implemented in 17 production cells).

Successfully coordinated the introduction of new products for Toyota, Ford, Chrysler, GM, Hitachi and Mitsubishi.

Developed a program to audit and monitor critical operations.

Smiths Medical, Manufacturing in medical devices. Position: Quality Jr. Engineer, Time Labored: Nov 2005- Aug 2007

Responsible for CAPA investigation, root cause analysis, customers complain and field trend analysis.

Active participation to assure compliance in Internal Policies and Procedures.

Assist with development of quality and operating procedures to assure alignment with current requirements.

Achievements

Performed detailed analysis of returned customer parts and used findings to drive Corrective and Preventative Action (CAPA) improvements.

Education:

Bachelor of industrial engineering. UABC.

High School: Cetys.

Master of health informatics: Purdue University (Initiating May 2019)

Certifications:

Certification of Green Belt (Institute Technologic of Monterrey ITESM) 2008.

Statistical (SPC) 2009 Core tools.

Internal auditor.

Lean Manufacturing.

Quality engineer certification.

Languages:s

(English and Spanish).

Software:

-SolidWorks, autocad, minitab, Smart scope, office (Word, PowerPoint, excel, outlook).

-Oracle

-Python/sublime, pycharm, Django.

Knowledge:

21CFR Part 820 and ISO 13485 quality systems regulations

GD&T.

DMAIC / FMEA / SMED / SPC / PokaYoke / Lean Mfg / Kaizen.

Extrusion process troubleshooting / scientific molding.

PPAS & AIAG



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