Familiarity with ISO 13485 and ISO 14971 is preferred, Experience using quality and statistical tools, including SPC, process capability analysis, Pareto analysis, and trend analysis, Strong analytical, problem-solving, and data interpretation skills, Excellent communication and cross-functional collaboration abilities, Lean Six Sigma Green Belt certification or equivalent experience is considered an asset, Experience with process validation, equipment qualification, manufacturing transfers, extrusion, injection molding, automation, or assembly processes is preferred, Proficiency in Microsoft Office applications and statistical software (Minitab preferred). Bachelor's degree in Engineering, Biomedical Engineering, Mechanical Engineering, Electrical & Electronics Engineering, Chemical Engineering, Industrial Engineering, Materials Science, or a related technical discipline, Minimum 3 years of experience in Quality Engineering, Manufacturing Engineering, Process Engineering, or a related role within a regulated manufacturing environment.