Quality Engineer

Colgate • Morristown, TN

4d • Onsite

About The Position

As a Quality Engineer, you will improve process capability by evaluating process data and implementing corrective actions to achieve plant KPI indicators. You will issue, maintain, control, and audit documentation required for Quality and cGMP compliance. This includes product specifications and process parameters, failure investigations and CAPAs, quality standards and guidelines, product recall investigations, vendor and supplier management, quality training, and statistical process control and process capability management.

You will support day-to-day quality matters involving packaging materials, raw materials, production, and consumer complaint investigations. The role also establishes and maintains quality systems in making and finishing areas; manages quality data, specifications, and related enterprise software setups; partners with suppliers; conducts investigations and root cause analysis; manages CAPAs; supports audits and GMP walkthroughs; assists with validation protocols and technology transfers; and provides operational support for packaging quality and production-line improvements.

Requirements

• Bachelor's degree.
• At least 4 years of experience in a manufacturing plant environment.
• At least 2 years of experience conducting failure investigations and Correction and Preventative Action (CAPA).

Nice To Haves

• Experience using SPC, Minitab, or other statistical tools.
• Experience in a regulated industry, such as FDA-regulated work.
• Knowledge of GMPs or ISO 9000.
• Experience in a Technology Transfer role.
• Experience using SAP or other plant-related computer systems.

Responsibilities

• Improve process capability by evaluating process data and implementing corrective actions to achieve plant KPI indicators.
• Issue, maintain, control, and audit documentation required for Quality and cGMP compliance.
• Manage product specifications and process parameter revisions and trending.
• Manage failure investigations and CAPAs, including root cause analysis.
• Maintain quality standards and guidelines and support product recall investigations.
• Manage vendor and supplier quality through audits, specification verifications, performance concerns, inspections, complaint handling, and continuous improvement.
• Prepare and facilitate quality training as required.
• Develop and manage SPC, process control attributes, and process capabilities throughout production.
• Support day-to-day packaging materials and raw materials quality concerns and production-area quality matters.
• Assist with consumer complaint investigations and CAPAs.
• Establish and maintain quality systems in making and finishing areas, including process control, capability, compliance, and KPI trending.
• Manage historical quality data, maintain specifications in enterprise software, and oversee system setups for raw materials, formulas, and process changes.
• Attend supplier meetings and Quality excellence programs.
• Support internal and corporate audits and GMP walkthroughs.
• Support the development of validation protocols and assist with technology transfers, component alignment, change controls, system setups, and operational support.
• Provide guidance on packaging quality issues, support EMOs, maintain relevant SOPs, and track KPIs to drive production-line improvements.
• Perform other duties and responsibilities as assigned.

Benefits

• Medical, dental, and vision coverage.
• Basic life insurance.
• Paid parental leave.
• Disability coverage.
• 401(k) retirement plan with company matching contributions, subject to eligibility requirements.
• At least 15 vacation/PTO days for salaried employees.
• 13 paid holidays.
• Paid sick leave based on role and location in accordance with local laws.
• Salaried employees may be eligible for discretionary bonuses, profit-sharing, and long-term incentives for executive-level roles.

What This Job Offers

• Job Type: Full-time
• Career Level: Mid Level