Engineer Medical Device

LEX B. PRICE

[***] 878-****-*** Saddlebrook Ave

***********@***.*** Pickens, SC 29671

SKILLS

In-depth knowledge of the Quality profession, FDA regulations (QSR/cGMP, ISO13485),

medical device manufacturing and computer programming. Programming capabilities: SQL,

TSQL, Java, C/C++, VB, C#, F#, ASP, WPF (.Net), script languages. Proficient in Word, Excel,

PowerPoint. Able to speak German and Spanish.

EXPERIENCE

ST. JUDE MEDICAL, Liberty, SC [1997-November 2012]

Quality Engineer

CREATED FDA-compliant quality system for new plant.

QUALIFIED two new plants and coordinated relocation of manufacturing.

CREATED, QUALIFIED and IMPLEMENTED computer program to track/analyze fall-out.

IMPLEMENTED cross-site documentation system. AWARDED special performance bonus.

CREATED, QUALIFIED and IMPLEMENTED computer program to track/analyze training.

DECREASED fallout through statistical methods and root-cause analysis.

CREATED, QUALIFIED and IMPLEMENTED computer program to track Receiving

Inspection. ELIMINATED 300,000 sheets paper annually (system is paperless).

INCREASED efficiency of Receiving Inspection by 20 percent through LEAN

MANUFACTURING.

CREATED paperless computer program to record manufacturing (DHR).

MAINTAINED COMPLIANCE of tool qualification system.

AUDITED cGMP compliance medical device manufacturing.

CREATED and maintained Document Control systems (computer programming).

INCREASED efficiency by 30 percent.

UPGRADED Corrective Action/Preventative Action (CAPA) system to be paperless.

MAINTAINED FDA-compliance of the system.

MEGADYNE MEDICAL PRODUCTS, Draper, UT [1994-1997]

Quality Engineer / Regulatory Affairs

REDUCED field failure and complaint rate 90% using FMEA, DOE, and modifying

production methods.

DEVELOPED STATISTICAL PROCESS CONTROL reducing inspection expense 25%.

REDUCED component defect rate 50% through vendor and supplier AUDIT, improving

their inspections and manufacturing methods.

EXPANDED compliance to FDA regulations by heading Quality Control Department and

training staff.

MAINTAINED COMPLIANCE of supplier quality and complaint handling systems.

THIOKOL, Brigham City, UT, [1987-1993]

Research Physicist / Quality Engineer

DEVELOPED electromechanical inspection, saving $2 million a year.

Applied statistical process control reducing inspections cost 25%.

DEVELOPED new inspection system reducing defects 20%.

WON research contracts and conducted research.

EDUCATION / CERTIFICATION

Master of Science, Instrumentation Physics, University of Utah, 1994

Bachelor of Science, Physics, Utah State University, 1987

ASQ certifications: CQE, CQA, CRE, CSQE.

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