<p>Job Title: Quality Engineer</p> <p>Reports to: Quality Operations Manager</p> <p>Job Function:</p> <p>The 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.), and internal requirements. The Quality Engineer plays a key role in audits, root cause analysis, and customer complaint management while driving continuous improvement across the site.</p> <p>Essential Duties and Responsibilities:</p> <p>Quality Systems and Compliance</p> <ul> <li>Support and maintain site quality systems in compliance with regulatory (ISO, GMP, FDA, etc.) and applicable customer requirements. </li><li>Lead internal audits, customer audits, and third-party audits; prepare documentation, support on-site activities, and ensure timely closure of audit findings. </li><li>Assist with document control, SOP updates, and change management activities. </li><li>Support risk assessments, control plans, and quality metrics reporting. </li></ul> <p>Root Cause Analysis & Corrective Actions</p> <ul> <li>Lead and facilitate root cause analysis using structured problem-solving tools (e.g., 5 Whys, Fishbone, FMEA). </li><li>Develop, implement, and track corrective and preventive actions (CAPAs) to ensure effectiveness and sustainability. </li><li>Partner with Operations and Engineering to address quality issues, reduce defects, and improve process capability </li></ul> <p>Customer Complaint Management</p> <ul> <li>Manage customer complaints from receipt through closure, including investigation, root cause analysis, corrective action development and implementation, and response preparation. </li><li>Coordinate cross-functional investigations to ensure timely, accurate, and professional customer responses. </li><li>Identify complaint trends and drive systemic improvements to prevent recurrence. </li></ul> <p>Manufacturing & Process Support</p> <ul> <li>Provide quality support to manufacturing operations, including deviation investigations and nonconformance management. </li><li>Support sampling, documentation, and shipment of raw materials, batch, and finished product samples to outside labs for testing. </li><li>Support new product introductions (NPI), validation protocols (IQ/OQ/PQ), and process changes and subsequent process change control from a quality perspective. </li><li>Review batch records, inspection data, and quality documentation as needed. </li></ul> <p>Continuous Improvement</p> <ul> <li>Analyze quality data to identify trends, risks, and improvement opportunities. </li><li>Participate in Lean, Six Sigma, or other continuous improvement initiatives. </li><li>Promote a culture of quality, compliance, and accountability throughout the organization. </li></ul> <p>Minimum Knowledge, Skills and Abilities:</p> <ul> <li>Bachelor's degree in Engineering, Quality, Chemistry, or a related technical field. </li><li>3+ years of quality engineering or quality assurance experience in a manufacturing environment. </li><li>Experience with audits, nonconformance investigations, customer complaint management, root cause analysis, CAPA development and implementation. </li><li>Working knowledge of GMP and quality management systems. </li><li>Strong analytical, organizational, and problem-solving skills. </li><li>Effective written and verbal communication skills. </li><li>Preference for Lean, Six Sigma or quality certification. </li><li>Familiarity with regulatory compliance requirements applicable to certifications such as organic, Halal, naturals etc… would be desirable. </li></ul> <p>Physical & Work Environment:</p> <ul> <li>Manufacturing environment with regular presence on the production floor. </li><li>Ability to sit, stand, walk, and occasionally lift up to 25 lbs. </li><li>Occasional travel for customer or supplier audits may be required. </li></ul>