Quality Engineering Senior

Duties: Responsible for leading supplier process capability, statistical assessment, and Measurement System Analysis (MSA) improvement activities in support of Supplier Production Process Approval (SPPA) remediation and Quality Management System integration. Evaluates supplier manufacturing and inspection data to determine process capability, measurement system adequacy, and appropriate process and inspection controls. Plans, executes, and reviews capability studies, Gage R&R/MSA, and other statistical evaluations for critical-to-quality characteristics. Leads improvement of inadequate measurement systems through evaluation of measurement methods, equipment, fixturing, operator technique, and inspection methodology. Provides technical direction for non-normal data, inadequate capability, measurement system variation, and other complex statistical issues. Works cross-functionally with Supplier Quality, Manufacturing, Development, Quality, and external suppliers to establish technically sound solutions and drive identified gaps through closure.

Skills: Advanced knowledge of statistical methods used in manufacturing and supplier quality, including process capability (Cp/Cpk and Pp/Ppk), statistical process control, sampling, and Gage R&R/MSA. Demonstrated ability to assess and improve measurement system performance, including identifying sources of repeatability and reproducibility variation and establishing appropriate corrective actions. Strong ability to evaluate data distributions, select appropriate statistical methods for normal and non-normal data, and determine the validity and limitations of capability assessments. Ability to translate statistical results into practical decisions regarding measurement methods, process controls, inspection strategies, and supplier remediation. Strong knowledge of CTQs, engineering drawings, GD&T, process validation, and risk-based quality principles. Demonstrated ability to independently resolve complex statistical and measurement-system issues and effectively communicate technical conclusions to suppliers and cross-functional stakeholders.

Education: Bachelor s degree in Engineering, Statistics, or another relevant technical discipline. Certification as a Quality Engineer (CQE), Six Sigma Black Belt, or other applicable quality/statistical certification preferred. Minimum of 7 years of experience in Quality Engineering, Supplier Quality, Manufacturing Quality, or a related technical role, with demonstrated experience in process capability analysis, statistical methods, and Measurement System Analysis (MSA) development and improvement. Medical device or other highly regulated industry experience strongly preferred. An equivalent combination of education, certification, and relevant experience may be considered.

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