suppliers ensuring Medtronic design requirements are met; coordinate root cause investigations of product or process non-conformances using six sigma methodology; establish process flows, coordinate process validations using Installation Qualification, Operational Qualification and Performance Qualification (IQ/OQ/PQ) protocols; oversee statistical analysis by using techniques including Gage R and R, ANOVA, variables data distribution, sample size calculation, statistical process control, and Capability and Normality Assessments; oversee and coordinate Critical Feature Identification (CFI), Critical to Quality (CTQ) determination, Process Failure Mode and Effect Analysis (PFMEA), and Design Failure Mode and Effect Analysis (DFMEA) activities; and coordinate inspection methods including variables and attribute. Must possess at least four (4) years' experience with each of the following: FDA regulations, 21 CFR Part 820, ISO 13485, ISO 14971, IEC 60601, CAPA, and GMP; Lean transformation projects, product transfers, cost savings and material replacement projects; Process characterizations and optimization using methodologies including DOE, Time studies, VAVE, and Lean Six Sigma; Identifying root cause of product or process non-conformances; Establishing process flows and conducting process validations using IQ/OQ/PQ; Gage R &R, ANOVA, variables data distribution, sample size calculation, statistical process control, and Normality Assessments; CFI, PFMEA, DFMEA, and CTQ; and Coordinating inspection methods including variables and attribute.