Quality Engineer

Hi,My name is Karthik Mutyala and I m a Recruitment Manager with Stark Pharma, specializing in pharmaceutical, biotechnology, and medical device roles. I came across your profile and wanted to see if you are open to new opportunities.If interested, please send me your updated resume along with the best number and time to reach you.Job Title: Quality EngineerLocation: Lafayette, INDuration: 6 12 Month ContractJob SummaryWe are seeking a Quality Engineer to support manufacturing quality and process improvement initiatives within a highly regulated manufacturing environment. This role will focus on quality systems, APQP activities, risk mitigation, process improvement, and cross-functional collaboration to ensure product quality and operational excellence.The ideal candidate will have experience in manufacturing quality engineering, root cause analysis, APQP methodologies, and production quality support.Key ResponsibilitiesDevelop, document, and maintain quality systems, procedures, and operating standardsSupport manufacturing process improvements and quality enhancement initiativesParticipate in design and product reviews to ensure quality, reliability, manufacturability, and compliance requirements are achievedExecute APQP activities and risk mitigation processes utilizing tools such as:Process Flow Diagrams (PFD)PFMEAControl Plans (CP)Conduct root cause analysis and implement corrective and preventive actionsCollaborate with cross-functional stakeholders to identify and mitigate manufacturing and process risksTrack quality improvement recommendations through implementation and effectiveness verificationAnalyze quality data, benchmarking results, and process capability metrics to drive continuous improvementCreate and maintain inspection plans and inspection accountability systemsReview production and engineering documentation including drawings, qualification reports, assembly instructions, and BOMsRequired QualificationsBachelor s degree in Engineering from an ABET-accredited program2+ years of Quality Engineering or related manufacturing experienceStrong understanding of manufacturing quality systems and process improvement methodologiesExperience with APQP, PFMEA, Control Plans, and Root Cause AnalysisStrong analytical, organizational, and communication skills