Applied Statistician

Position Summary - This is an Applied Statistician role which will support Quality Assurance and Operations. The Company site inSan Diegoperforms a high volume of manufacturing for multiple in-vitro diagnostic product lines. This role conducts analysis of data related to quality control for final product, in-process manufacturing, and intermediates. The individual in this role will also support validation efforts in operations, in aspects of study design and data analysis. Key is the statistically proper treatment of measurement data and subsequent drawing of the right conclusion(s). Key Features- - Assure the product development, manufacturing and release process with best practices in statistical data analysis in order to insure correct decisions on key questions in line with regulatory requirements. - Immediately support validation study designs for statistical validity and data analysis. - Immediately assess in-process and final product disposition sampling rationale based on 510K/PMA claims. - Teach DMAIC & DFSS statistical techniques and supporting related process excellence projects on a weekly basis to a group of 10 - 20 colleagues. - Defend current data treatment practices in case of a regulatory body audit. - Troubleshoot product and process deviations on an interim basis as issues occur through data analysis. - Adhere to 21 CFR Part 820 Medical Device regulations. - Advance the QA function in terms of data analysis capability. - Maintain records of data treatment and analyses techniques for audit purposes. Basic Requirements - - Masters in Statistics / Mathematics or demonstrated equivalent experience. - Preferred BS or education in an Engineering discipline. - Multiple years of experience in manufacturing or testing related industry and in applied statistics. - Cordial team player. - Ability to communicate both written and orally across all levels of the organization. - Experience with JMP, Excel, R and/or SAS. This is an excellent opportunity to become a part of leading Medical Device company inSouthern California. Please submit your resume to be considered for an interview.

To find out more about Real please visit www.realstaffing.com [1]

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[1] http://www.realstaffing.com