Quality Engineer
Job in
Paris, Bourbon County, Kentucky, 40361, USA
Listed on 2026-09-27
Listing for:
Employee Workplace
Full Time
position Listed on 2026-09-27
Job specializations:
-
Quality Assurance - QA/QC
Quality Engineering, Regulatory Compliance Specialist, QA Specialist - Analyst/Manager
Job Description & How to Apply Below
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.
- 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.
- 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
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