Quality Engineer

Job Title: Quality Engineer Reports to: Quality Operations Manager Job Function 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. Essential Duties and Responsibilities Quality Systems and Compliance Support 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 Actions Lead and facilitate root cause analysis using structured problem‑solving tools (e.g., 5 Whys, Fishbone, FMEA). Develop, implement, and track corrective and preventive actions (CAPAs) to ensure effectiveness and sustainability. Partner with Operations and Engineering to address quality issues, reduce defects, and improve process capability. Customer Complaint Management Manage 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 Support Provide 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 Improvement Analyze 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. Minimum Knowledge, Skills and Abilities 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. Strong analytical, organizational, and problem‑solving skills. Effective written and verbal communication skills. 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. Physical & Work Environment Manufacturing environment with regular presence on the production floor. Ability to sit, stand, walk, and occasionally lift up to 25 lbs. Occasional travel for customer or supplier audits may be required. #J-18808-Ljbffr Bradford Labs