Quality Engineer

About the role

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.

Responsibilities

• 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.
• Aid with document control, SOP updates, and change management activities.
• Support risk assessments, control plans, and quality metrics reporting.
• 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.
• Manage customer complaints from receipt through closure, including investigation, root cause analysis, corrective action development and implementation, and response preparation.
• Cook up with cross-functional investigations to ensure timely, accurate, and professional customer responses.
• Identify complaint trends and drive systemic improvements to prevent recurrence.
• 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.
• 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.

Requirements

• 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.