Quality Engineer

Job Responsibilities:Develop inspections & tests to verify product qualityTrain QA teams on inspection implementationPartner with R&D & Mfg. teams to resolve issues & implement corrective actionsEnsure adherence to all quality standardsAssess & supervise supplier performanceConduct supplier audits Partner on continuous improvement initiativesPartner with R&D engineering to review project docsDevelop, implement, and maintain the QMSConduct internal auditsSupport the identification & mitigation of product & process risksImplement & maintain risk management processesStay updated on relevant industry regulations & standardsSupport regulatory submissions & provide audit documentation as neededJob Requirements: Bachelor's degree in Engineering or similar 4+ years of quality engineering experience within the med device industryStrong knowledge of FDA regulations, ISO standards, and other relevant quality reqsExperience with risk management processes & techniquesExcellent verbal & written communication skillsExtreme attention to detail – committed to delivering high-quality results