Process Quality Engineer

Barbara M. Traub

**** ********* **. *****, ** ***02 • 214-***-**** • *******.*****@*****.***

SUMMARY OF SKILLS:

• Experience in ISO/FDA regulated industry

• ISO13485 certified lead auditor

• Proficient in problem solving and data analysis

EDUCATION:

Bachelor of Science in Biomedical Engineering December 2008

Florida International University. Miami, FL GPA: 3.2/4.0

Senior Design Project (Jan 2008-Aug 2008)

Participated in a multi-functional team to develop a product according to customer needs. Used fiber optics and worked with near-infrared technology to develop a flexible hand-held imaging probe for diagnosing breast cancer.

• Team leader and responsible for project management, design of probe, material research, and testing.

• Hands on experience developing the device; CNC operating machine, soldering, fiber optic cutting and polishing, and prototype machining.

• Tested product to ensure validity of design.

• Experience in FMEA risk analysis.

• Created computational 3D models using SolidWorks, tested arrangement of optical fibers using MATLAB, and compared/contrasted material strength and fatigue failure using COSMOS tools.

WORK EXPERIENCE:

Process Quality Engineer (Nov 2009- present)

Stryker. Flower Mound, TX.

Communications Division (Surgical Lights and Equipment/Anesthesia Booms)

Responsible for initiating preventive and corrective actions with regards to product non-conformances (NCRs) observed at incoming, final quality control, and manufacturing floor.

• Managed NCR process for Booms and Lights (BNL) unit.

• Executed preventive and corrective actions (CAPA) on both internal and external quality issues.

• Experience as a project manager tracking completion of CAPAs.

• Coordinated containment activities to achieve complete segregation of non-conforming products/components.

• Successful at problem solving/root cause identification.

• Coordinated and participated in supplier conference calls.

• Team lead of material review board (MRB).

• Tracked external/internal quality performance by using statistical analysis of non-conforming data and presenting adverse trends to non-conforming monitoring board (NCMB).

• Initiated and executed validation plans for test fixtures used at incoming and final quality inspection (IQ, OQ and PQ).

• Updated risk analysis file (FMEA) with feedback from non-conforming data.

• Responsible for various product sustaining activities including updating existing divisional procedures and related documents as a result of internal audit findings or non-conformance/complaint data.

• Participated in improvement projects related to non-conformance findings not escalated to CAPAs.

• Trained quality inspectors, quality technicians, and production assemblers on quality related procedures including GMP and GDP.

Neurophysiologist (Jan 2009-Nov2009)

Neurofocus. Dallas, Texas.

Tested the effectiveness of ads and other marketing material using EEG technology for market research purposes. Worked in the research lab of Frito Lay (fortune 100 company) recording and analyzing the electrical signals of consumers being presented with marketing stimuli.

• Clinical setting, recording the neural activity of 7 subjects/day.

• Conditioned the signals obtained using high/low-pass filters, and removing EEG artifacts (eye-blinking, facial movements, component noise) from these recordings.

• Used MATLAB for digital signal processing techniques.

Floor Leader (July 2002-Oct 2006)

Barnes and Noble #785. Miami, Florida.

Started as a bookseller and quickly began to get promoted within bookstore departments. Worked in customer service desk, shipping and receiving area, general floor, buyback, and return area. Gained insight to every aspect of the bookstore (making purchase orders, floor organization, online orders, receiving... etc) and then finally got promoted to floor leader. Directly supervised seasonal and temporary hires and created a team-oriented environment being able to start/finish projects.

• Attentive to detail, resourceful, and able to work under minimal or no supervision

• 4+ years of customer service experience

• Leadership qualities, managing 20+ seasonal employees

• Energetic, self-starter, with project management skills

TECHNICAL EXPERTISE:

Agile (PLM system), Oracle (ERP system), SolidWorks, AutoCAD, MATLAB, SIMULINK, BIOPAC, Photoshop

Microsoft Office Suite: Word, Excel, PowerPoint, Project, Access, Outlook

CERTIFICATES:

ISO13485 Certified Lead Auditor.

KT Problem Solving & Decision Making

Texas A&M Risk Management through Product Life Cycle

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