Must possess at least two (2) years of experience with each of the following: DMAIC methodology; Minitab, DOE, SPC, Variable Gage R & R, ANOVA, t-test, regression analysis, Process Capability, and Confidence & Tolerance interval analysis; Product and Process risk utilizing FMEA and ISO 14971, A3 thinking, PDCA, 5 Why’s, and Ishikawa (Fishbone); QMS process, CTQ identification, FDA 21 CFR Part 820, ISO 13485, and GDP; IQ/OQ/PQ, CAPA and RCA; PSUR, CER and TD files as per EU MDR and global requirements; and PPAP, CP, PF, MR for transfer projects. Utilize design development, analysis and statistical tools including Minitab, and statistical methods including DOE (Design of Experiments), SPC (Statistical Process Control), Variable Gage R & R (Reliability and Repeatability), ANOVA (analysis of Variance), t-test, regression analysis, Process Capability, and Confidence & Tolerance interval analysis.