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Job Title: Quality EngineerÂ
Reports to:Â Quality Operations Manager
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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.
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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.
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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.Â
- 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.
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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.
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