Quality Engineer

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

Now Hiring Quality Engineer

1st Shift (Monday-Friday)

Up to $49.00/Hour

Schedule: 1st Shift, Monday through Friday

Are you passionate about driving quality, compliance, and continuous improvement in highly regulated manufacturing environments? We're seeking an experienced Quality Engineer to lead quality assurance initiatives, support regulatory compliance, and help deliver exceptional products through data-driven analysis and process improvement.

Key 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.

Qualifications

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

Employee Benefits

• Medical, dental, vision, and pet insurance
• 401(k) Retirement Savings Plan
• Employee Assistance Program (EAP)
• Commuter/Parking Accounts
• People Perks Program
• Health Savings Account (HSA)
• AD&D Insurance

About Us

Advantage Technical connects top- talent in technology, engineering, and technical fields with forward-looking companies.

Advantage Technical is an equal opportunity employer. All applicants will receive consideration without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, disability, or veteran status, or any other legally protected status. Advantage Technical offers reasonable accommodations for qualified individuals with disabilities; contact your local branch for inquiries. Advantage Technical is an E-Verify employer. See our Privacy Notice for Candidates and Employees/Contractors at https://smgroupna.com/privacy-notice-for-candidates-and-employees-contractors.