Lead Quality Engineer – Medical Devices & CAPA

Teleflex; Northern (KY); Hybrid; USD 65,000 - 90,000; Full time

Job summary

Ingenyx is seeking a Quality Engineer 3 to join our manufacturing QA team in Kentucky. You will lead CAPA/NC activities, investigate customer complaints, guide process validations, and support audits. Strong knowledge of QSR, CFR, cGMP, ISO and root-cause tools is essential.

Manufacturing experience and ASQ QA Auditor preferred; BS degree required or equivalent certification. The role emphasizes collaboration, problem solving, and adherence to quality systems to drive compliant product quality

Qualifications

• Bachelor’s degree preferred or ASQ Certified Quality Engineer.
• 3+ years of Quality Assurance experience required.
• Manufacturing experience required; regulated or medical industry experience preferred.

Responsibilities

• Nonconformance (NC) and CAPA coordination and processing.
• Customer complaint investigations.
• Process validations – guide and review protocols and final reports.
• Customer change-notification evaluations.
• Internal and external audit support.
• Quality improvement initiatives.
• Compliance with Ingenyx and local procedures and policies.
• Training and other QA duties as assigned by QA Manager.

Skills

QA knowledge

CAPA NC

Root Cause Analysis

DOE SPC

Minitab

SAP ERP

MS Office

Auditor cert

Design Control

Statistical methods

Education

Bachelor's degree preferred

ASQ Certified Quality Engineer

Tools

Minitab

SAP ERP

Excel

DOE tools

Job description

Ingenyx is seeking a Quality Engineer 3 to join our manufacturing QA team in Kentucky. You will lead CAPA/NC activities, investigate customer complaints, guide process validations, and support audits. Strong knowledge of QSR, CFR, cGMP, ISO and root-cause tools is essential.

Manufacturing experience and ASQ QA Auditor preferred; BS degree required or equivalent certification. The role emphasizes collaboration, problem solving, and adherence to quality systems to drive compliant product quality