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Validation Engineer

Company Name: Robling Medical, Inc.
(More from this company)
Location: Youngsville, North Carolina, United States
Date Posted: 1/31/2013
Posting Expiry Date: 3/18/2013
Pay Rate: Negotiable

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Robling Medical, Inc. is seeking a Validation Engineer. The ideal candidate will have:
ò Solid experience in equipment and process validation
ò Strong analytical skills relating to equipment and processes
ò Excellent written communication & documentation skills
ò Strong intellectual curiosity & technical aptitude
ò Intermediate level statistical analysis skills
ò Experience in medical device manufacturing
ò B. S. in Engineering
General Summary

The Validation Engineer (VE) is primarily responsible for validating processes and equipment. The validation process includes writing protocols, executing protocols, testing and inspecting samples, analyzing data and preparing reports utilizing the data that was collected. The VE is required to know and apply the appropriate statistical analysis tools to the data collected. The
VE will be required to take a key role in the training of manufacturing personnel in the proper operation of equipment and process for which he/she has been responsible for validating. The Validation Engineer will be required to document or update procedures and specifications related to the processes he/she has been responsible for validating. The Validation Engineer may be required to participate in Internal Quality Audit Program.

Primary Duties and Responsibilities

ò Prepare, document and execute validation protocols, engineering studies and designs of experiments (DOEs) and prepare subsequent reports
ò Test and inspect samples
ò Analyze data and prepare reports
ò Perform and document root cause analysis for product and process failures; participate and lead in the corrective and preventive actions
ò Audit and confer with representatives of material and component vendors to obtain information related to supply quality, and vendor quality standards
ò Review technical problems and procedures and recommend solutions to problem or changes in procedures
ò Develop and analyze statistical data and product specifications to determine present standards and establish proposed quality and reliability expectancy of finished product
ò Train manufacturing personnel in proper operation of equipment and processes to be validated
ò Develop, document and update standard operating procedures, specifications and assembly instructions
ò Support manufacturing efforts by troubleshooting equipment and process failures
ò Lead and implement process improvement efforts throughout the manufacturing plant
ò Participate as a member of the internal audit team by conducting internal audits

Required Qualifications

ò Ability to utilize MiniTab
ò Proficiency in intermediate level statistical analysis
ò Proficiency in organizing, tracking and reporting status of projects for which he/she is responsible.
ò Strong analytical/troubleshooting skills, including cause and effect analysis
ò Solid understanding of basic electrical and mechanical design necessary in order to trouble shoot equipment that is being validated
ò Excellent written communication skills
ò Strong verbal communications skills
ò Exceptional technical aptitude
ò Experience using Microsoft Office software in a network computer environment
ò Proven ability to multi-task between various responsibilities
ò B.S. in Engineering (Industrial, Mechanical, Electrical, Quality)

Preferred Qualifications

ò Certified Statistical Quality Engineer
ò Ability to perform basic electrical troubleshooting of equipment using multimeter and equipment schematics
ò 2-5 yearsÆ experience as a Validation/Quality Engineer validating processes and equipment

Environment & Working Conditions

ò Ability to lift at least 30 lbs
ò Standing for long periods of time
ò Bending
ò Sitting for long periods of time
ò Ability to use rulers, calipers/micrometers, height gage, tensile and compression testing equipment, pressure decay tester, burst tester, multi-meter
ò Visual - constant visual attention
ò Primary work environment in clean rooms where gowns and hair covers are required.