Lead Quality Engineer - CAPA & Validation

Teleflex; Trenton (GA); On-site; USD 85,000 - 110,000; Full time

Job summary

Ingenyx is seeking a Quality Engineer 3 to provide leadership and support to manufacturing as part of the Quality team. Responsibilities include NC/CAPA coordination, customer complaint investigations, and validation activities to ensure compliant processes and products.

Ideal candidates have 3+ years QA experience in manufacturing, knowledge of regulatory frameworks, and strong communication skills. The role emphasizes quality improvements, audits, and collaboration across functions within

Qualifications

• Bachelor’s degree preferred, or equivalent ASQ Certified Quality Engineer certification; strong communication and presentation skills required.
• 3+ years of Quality Assurance experience required.
• Manufacturing experience required; regulated or medical industry experience preferred.

Responsibilities

• Nonconformance (NC) & CAPA – Lead Quality activities for Conductor Material Review Board coordination, inspection methods, NC containment/correction/closure, and CAPAs. Analyze trend data and drive improvements.
• Customer Complaint Investigations – Lead Conductor complaint investigations, confirmation, and corrective actions. Serve as the primary customer contact for complaint communications and drive improvements based on trends.
• Process Validations – Guide and review protocol development, validation execution, and final reports for acceptance.
• Quality & Cost Improvement – Lead and participate in short-term product and process improvement projects.
• Production & Process Controls – Review, revise, and approve Manufacturing Procedures, Test Method validations, Quality Inspection Plans, and process run sheets.
• Auditing – Perform internal and process audits; participate in vendor audits as needed; and support Back Room activities during FDA and Notified Body audits.
• Documentation Control – Review Customer Product Specifications. Initiate Engineering Change Notices and review/approve changes as needed.
• Training – Conduct QA training certifications for new Production operators.
• Engineering Support – Support product improvements through quality planning, risk evaluation, and validation.
• Other Duties – Perform additional QA responsibilities as assigned by the QA Manager.

Skills

CAPA

Complaint investigations

Validation concepts

Continuous improvement

Root cause analysis

Process auditing

Quality planning

Regulatory knowledge

Minitab familiarity

DOE

SPC

Education

Bachelor’s degree

ASQ Certified Quality Engineer

Tools

Minitab

SAP ERP

Job description

Ingenyx is seeking a Quality Engineer 3 to provide leadership and support to manufacturing as part of the Quality team. Responsibilities include NC/CAPA coordination, customer complaint investigations, and validation activities to ensure compliant processes and products.

Ideal candidates have 3+ years QA experience in manufacturing, knowledge of regulatory frameworks, and strong communication skills. The role emphasizes quality improvements, audits, and collaboration across functions within