On-the-Floor Quality Engineer for Medical Devices

Aurora Lifesciences; Yorkshire, Northern (VA, KY); Hybrid; USD 85,000 - 105,000; Full time

Job summary

Aurora Lifesciences seeks a hands-on Quality Engineer at our precision medical device manufacturing site in the United States. You’ll be on the shop floor, collaborating with Production, Engineering and Supply Chain to ensure products meet regulatory and customer standards.

You will investigate issues, manage non-conformances, lead CAPA and root cause investigations, and drive improvements to protect patient safety and product quality across processes.

Qualifications

• Must have experience in a regulated manufacturing environment (medical device preferred).
• Proficient in reviewing drawings, specifications and inspection data.
• Experience with non-conformance handling, CAPA and root cause investigations.
• Ability to analyze quality data and support audits and regulatory records.

Responsibilities

• Review engineering drawings, specifications, inspection results and CMM reports.
• Support dimensional inspection using micrometers, verniers and height gauges.
• Complete product and batch release activities.
• Ensure quality records, documentation and traceability are audit-ready.
• Inspect incoming materials and review supplier certificates.
• Collaborate with suppliers to resolve quality or documentation concerns.
• Support internal, customer, supplier and third-party audits.
• Analyze quality data and report trends and KPIs.

Skills

Non-conformance mgmt

CAPA

Root cause analysis

Drawings reading

Dimensional inspection

Data analysis

Audits

Records mgmt

Education

Bachelor's degree in Engineering

Tools

ERP/MRP systems

Power BI

CMM software

Job description

Aurora Lifesciences seeks a hands-on Quality Engineer at our precision medical device manufacturing site in the United States. You’ll be on the shop floor, collaborating with Production, Engineering and Supply Chain to ensure products meet regulatory and customer standards.

You will investigate issues, manage non-conformances, lead CAPA and root cause investigations, and drive improvements to protect patient safety and product quality across processes.