Quality Engineer - cGMP, CAPA & Audit Expert

Employee Workplace; Paris (KY); On-site; USD 56,000 - 79,000; Full time

Job summary

Employee Workplace in the United States is seeking a Quality Engineer to lead quality assurance initiatives, support regulatory compliance, and drive continuous improvement in a highly regulated manufacturing environment.

You will manage CAPAs, audits, and validation activities, perform root-cause analysis, and collaborate with customers and suppliers to ensure product quality and compliance. This is a first-shift, Monday–Friday position with compensation up to $49 per hour.

Qualifications

• Bachelor's degree in Engineering, Quality, or related field.
• Minimum 5 years of Quality Engineering experience.
• Experience in pharmaceutical, biotechnology, or chemical manufacturing environments.
• Strong knowledge of cGMP regulations, ISO standards, quality systems, audits, CAPA, validation, and compliance programs.
• Excellent analytical, problem-solving, and communication skills.

Responsibilities

• Lead quality assurance and continuous improvement projects.
• Support regulatory compliance with cGMP, ISO 9000, FDA, ICH Q7, and related quality standards.
• Manage and investigate CAPAs, customer complaints, quality events, validation activities, and process improvements.
• Perform root cause analysis and develop corrective and preventive actions.
• Analyze quality data, identify trends, and recommend process enhancements.
• Coordinate internal, customer, certification, and surveillance audits.
• Collaborate with customers, vendors, and internal teams to resolve quality concerns and ensure compliance.
• Support validation, stability, and statistical process control activities.

Skills

Quality engineering

Analytical skills

Problem solving

Communication

Education

Bachelor's degree in Engineering, Quality, or related field

Job description

Employee Workplace in the United States is seeking a Quality Engineer to lead quality assurance initiatives, support regulatory compliance, and drive continuous improvement in a highly regulated manufacturing environment.

You will manage CAPAs, audits, and validation activities, perform root-cause analysis, and collaborate with customers and suppliers to ensure product quality and compliance. This is a first-shift, Monday–Friday position with compensation up to $49 per hour.