Quality Engineer - cGMP & ISO Compliance

Advantage Technical; Paris (KY); On-site; USD 39,000 - 68,000; Full time

Benefits offered by this job

Medical insurance

Dental/ Vision insurance

401(k) Retirement Savings Plan

Employee Assistance Program (EAP)

Commuter/Parking Benefits

Health Savings Account (HSA)

AD&D Insurance

Job summary

Advantage Technical is seeking a Quality Engineer to lead quality assurance initiatives and foster compliance in regulated manufacturing environments. The role emphasizes data-driven analysis, CAPA handling, and collaboration with customers and suppliers.

Ideal candidates will have a Bachelor's degree in Engineering or Quality, at least 5 years in quality engineering within pharma/biotech/chemical settings, and strong knowledge of cGMP, ISO standards, and audits.

Qualifications

• Bachelor's degree in Engineering, Quality, or a related scientific 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

CAPA management

Root cause analysis

Data analysis

Regulatory compliance

Audits

Education

Bachelor's degree in Engineering/Quality

Job description

Advantage Technical is seeking a Quality Engineer to lead quality assurance initiatives and foster compliance in regulated manufacturing environments. The role emphasizes data-driven analysis, CAPA handling, and collaboration with customers and suppliers.

Ideal candidates will have a Bachelor's degree in Engineering or Quality, at least 5 years in quality engineering within pharma/biotech/chemical settings, and strong knowledge of cGMP, ISO standards, and audits.