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POST DATE 8/12/2016
END DATE 12/19/2016
JOB DESCRIPTIONPOSITION RESPONSIBILITIES:
* Lead test method validation for complex electro-mechanical laboratory systems.
* Prepare and review Qualification/Validation Test Plans and Reports for assigned projects, including test equipment and built in software.
* Execute testing and/or provide technical support for technicians performing the testing. Assure the resolution of all issues raised by the testing.
* Perform statistical data analysis (t-test, sample size determination, Gage R&R, ANOVA etc.) using Minitab.
* Interpret results and prepare test reports.
* Implement Statistical Process Control to monitor and trend large sets of manufacturing data.
* Conduct experiments of moderate complexity to solve process and product problems by developing responses, identifying and testing dynamics, protocol development, conducting or supervising tests, reducing data, performing statistical analysis using statistical tools, drawing conclusions and documenting results. For complex data acquisition and data reduction, sets up complex worksheets (macro or formula based) and test functionality.
* Provide qualitysystem guidance to ensure compliance to SOPs, internalrequirements, and appropriate external regulatory standards.
* Without much supervision, able to quickly learn and understand SOP requirements, document management systems like Agile and Documentum.
* Able to lead a team, provide direction on project deliverables.
* Perform/lead other tasks as assigned by manager.
* Bachelor's in Engineering
* 5+ years Qualityengineering or technical experience
* Expertise in statistical analysis and software (Minitab)
* Previous experience with validation/qualification activity, including software
* Project management experience
* Experience in problem solving techniques and engineering statistical tools and methodologies. ASQ Certified Excellent oral and technical writing skills.
* Self-starter and have the ability to work well with minimum supervision.
* Ability to work in a team environment.
* Computer Skills (Microsoft- Word, Excel, Project, PowerPoint).