Quality Engineer (Arlington Heights)

Quality EngineerLocation: Arlington Heights, ILReports to: Quality Engineering ManagerJob SummaryThe Quality Engineer is responsible for maintaining and improving quality engineering processes, systems, and standards across the organization. This role plays a key part in ensuring product quality, regulatory compliance, and continuous improvement initiatives.Key ResponsibilitiesDevelop and implement inspection, testing, and evaluation methods to ensure product quality and reliabilityDesign sampling procedures and create documentation for recording, analyzing, and reporting quality dataEstablish and manage processes for disposition of nonconforming materials, including cost impact assessmentLead and support product testing activities, including data collection and analysis related to materials, processes, and product performanceCreate training materials and conduct training sessions on quality systems and proceduresPartner with Product Engineers and Quality Program Managers to support customer-related quality issuesEnsure accuracy, integrity, and availability of quality data; compile and report on quality metricsInitiate, track, and drive corrective actions (CAPAs) to completionSupport internal and external quality audits, including preparation and follow-up activitiesDevelop, implement, and maintain quality standards for manufacturing processes and finished productsDesign and improve methods for evaluating product and equipment precision and accuracyInvestigate quality issues, including returned products, and recommend corrective actionsEstablish programs to evaluate production and measurement equipment performanceApprove product, process, and equipment qualificationsServe as a liaison with regulatory agencies as neededQualificationsBachelor's degree in Engineering or a related field (or equivalent experience)Minimum of 6 years of experience in quality engineeringAt least 3 years of experience in the medical device, pharmaceutical, or biotechnology industryWet lab experience is needed (Pharma, Med Device, Life Science, Health Care.)Strong knowledge of ISO 13485 standardsExperience with quality systems and processes such as CAPA, SCAR, and NCMRFamiliarity with FDA and ISO regulatory requirements (certifications preferred)What We OfferComprehensive medical, dental, and vision insuranceLife insurance coverageShort-term and long-term disability benefits401(k) with company matchPaid vacation and sick timeTuition reimbursementQualified applicants will receive consideration for employment without regard to race, color, age, religion, sex, sexual orientation, gender identity, national origin, disability, protected veteran status, or genetic information.