Quality Assurance Engineer

The Quality Engineer supports a chemical mixing / medical device manufacturing operation, ensuring compliance with applicable quality system regulations while providing direct shop-floor quality support. This role is responsible for complaints management, CAPA, change control, and supplier quality management, and works cross-functionally with Manufacturing, Engineering, Supply Chain, and Regulatory Affairs to drive product quality, process robustness, and continuous improvement. In This Position, You Will Have the Opportunity To: Shop Floor QualityProvide day-to-day quality support for operationsPerform batch record review, deviations, nonconforming material investigations, and process troubleshootingDevelop and implement test methods and procedures for inspecting, testing and evaluating product and processesComplaints & Post-Market SurveillanceLead and/or participate in complaint investigations in accordance with FDA QSR, ISO 13485, and customer requirementsPerform root cause analysis and ensure appropriate corrective and preventive actionsConduct trend analysis, escalation, and regulatory reporting (e.g., MDR support as applicable)Interface with customers regarding complaint investigations and responses when requiredCorrective and Preventive Action (CAPA)Own and manage CAPA records, from initiation through effectiveness verificationApply structured problem-solving tools (e.g., 5-Why, Fishbone, FMEA)Monitor CAPA metrics, timeliness, and effectiveness to ensure sustained improvementAddress CAPAs identified during internal and external auditsChange ControlParticipate in change control activities related to materials, suppliers, processes, equipment, and documentationAssess quality and regulatory impact of proposed changes, including risk evaluationsEnsure changes are implemented in compliance with customer requirements and applicable regulationsAssist with validation and verification activities as requiredSupplier Quality ManagementExecute Supplier Quality initiatives and programs with activities such as supplier qualification, auditing, SCAR management, and PPAPPerform supplier qualification, monitoring, and performance managementReview and approve supplier documentation (COAs, specifications, quality agreements)Participate in supplier audits, issue supplier corrective actions, and track resolutionMaintain incoming inspection strategies and supplier risk assessmentsQuality System & ComplianceEnsure compliance with applicable regulations (FDA’s QMSR, ISO 13485, EUMDR, ISO 14971)Participate in internal, customer, and regulatory audits, including preparation and response activitiesPerform data analysis and reporting of quality metrics (scrap, rework, complaints, CAPA)