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. • Audits and Compliance: Lead internal audits, customer audits, and third-party audits; prepare documentation, support on-site activities, and ensure timely closure of audit findings. • Document Control and Updates: Assist with document control, SOP updates, and change management activities. • Risk Assessments and Quality Metrics: Support risk assessments, control plans, and quality metrics reporting. • Root Cause Analysis and 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. • Customer Complaint Management: Manage customer complaints from receipt through closure, including investigation, root cause analysis, corrective action development and implementation, and response preparation. • Cross-Functional Investigations: 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:

• Quality Support to Manufacturing Operations: Provide quality support to manufacturing operations, including deviation investigations and nonconformance management. • Sampling and Documentation: Support sampling, documentation, and shipment of raw materials, batch, and finished product samples to outside labs for testing. • New Product Introductions and Process Changes: Support new product introductions (NPI), validation protocols (IQ/OQ/PQ), and process changes and subsequent process change control from a quality perspective. • Review of Batch Records and Quality Documentation: Review batch records, inspection data, and quality documentation as needed.

Continuous Improvement:

• Analyze Quality Data: Analyze quality data to identify trends, risks, and improvement opportunities. • Participate in Continuous Improvement Initiatives: Participate in Lean, Six Sigma, or other continuous improvement initiatives. • Promote a Culture of Quality: Promote a culture of quality, compliance, and accountability throughout the organization.

Minimum Knowledge, Skills and Abilities:

• Education: Bachelor's degree in Engineering, Quality, Chemistry, or a related technical field. • Experience: 3+ years of quality engineering or quality assurance experience in a manufacturing environment. • Skills: Experience with audits, nonconformance investigations, customer complaint management, root cause analysis, CAPA development and implementation. • Knowledge: Working knowledge of GMP and quality management systems. • Analytical and Organizational Skills: Strong analytical, organizational, and problem-solving skills. • Communication Skills: Effective written and verbal communication skills. • Certification: Preference for Lean, Six Sigma or quality certification. • Familiarity with Regulatory Compliance: Familiarity with regulatory compliance requirements applicable to certifications such as organic, Halal, naturals, etc.

Physical & Work Environment:

• Manufacturing Environment: Manufacturing environment with regular presence on the production floor. • Physical Demands: Ability to sit, stand, walk, and occasionally lift up to 25 lbs. • Travel: Occasional travel for customer or supplier audits may be required.