Quality Systems Engineer

ResponsibilitiesProvide quality support to production lines and catheter assembly processesEnsure compliance with GMP, GDP, and ISO ***** requirementsInvestigate NCRs, process deviations, and manufacturing failuresLead root cause analysis activities using 8D, 5 Why's, Fishbone, and CAPA methodologiesMonitor quality KPIs, scrap trends, and rework performanceSupport process validations, engineering changes, and continuous improvement initiativesParticipate in internal, corporate, and regulatory auditsCollaborate with Manufacturing, Process Engineering, Validation, and Quality teamsQualificationsBachelor's degree in Engineering or related field2–3 years of experience as a Quality Engineer within the medical device industryExperience in catheter manufacturing or medical device assembly operationsKnowledge of ISO *****, FDA 21 CFR Part 820, and document control systemsHands-on experience supporting high-volume production floor operationsIntermediate to advanced English level#J-*****-Ljbf...