Quality Engineering S

Quality EngineerReports to: Quality Operations ManagerThe Quality Engineer supports quality systems and product quality for a personal care contract manufacturing operation. This role has no direct reports and works cross-functionally with Operations, Engineering, R&D, and Customer Service to ensure compliance with customer, regulatory (ISO, FDA, Organic, etc.), The Quality Engineer plays a key role in audits, root cause analysis, and customer complaint management while driving continuous improvement across the site.Quality Systems and ComplianceSupport and maintain site quality systems in compliance with regulatory (ISO, GMP, FDA, etc.) and applicable customer requirements.Lead internal audits, customer audits, and third-party audits; prepare documentation, support on-site activities, and ensure timely closure of audit findings.Assist with document control, SOP updates, and change management activities.Support risk assessments, control plans, and quality metrics reporting.Root Cause Analysis & Corrective ActionsLead and facilitate root cause analysis using structured problem-solving tools (e.g., Partner with Operations and Engineering to address quality issues, reduce defects, and improve process capabilityCustomer Complaint ManagementManage customer complaints from receipt through closure, including investigation, root cause analysis, corrective action development and implementation, and response preparation.Coordinate cross-functional investigations to ensure timely, accurate, and professional customer responses.Identify complaint trends and drive systemic improvements to prevent recurrence.Manufacturing & Process SupportProvide quality support to manufacturing operations, including deviation investigations and nonconformance management.Support sampling, documentation, and shipment of raw materials, batch, and finished product samples to outside labs for testing.Support new product introductions (NPI), validation protocols (IQ/OQ/PQ), and process changes and subsequent process change control from a quality perspective.Review batch records, inspection data, and quality documentation as needed.Continuous ImprovementAnalyze quality data to identify trends, risks, and improvement opportunities.Participate in Lean, Six Sigma, or other continuous improvement initiatives.Promote a culture of quality, compliance, and accountability throughout the organization.Bachelor's degree in Engineering, Quality, Chemistry, or a related technical field.3+ years of quality engineering or quality assurance experience in a manufacturing environment.Experience with audits, nonconformance investigations, customer complaint management, root cause analysis, CAPA development and implementation.Working knowledge of GMP and quality management systems.Preference for Lean, Six Sigma or quality certification.Familiarity with regulatory compliance requirements applicable to certifications such as organic, Halal, naturals etc… would be desirable.Manufacturing environment with regular presence on the production floor.Occasional travel for customer or supplier audits may be required.