Quality Engineer

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

We’re looking for a hands‑on Quality Engineer who enjoys being close to the product, the process and the people making it happen. You’ll be joining a precision manufacturing environment where quality really matters. The work you do will have a direct impact on product performance, customer satisfaction and, ultimately, patient safety. This isn’t a role where you’ll spend all day behind a desk. You’ll be visible on the shop floor, working closely with Production, Engineering, Inspection and Supply Chain to solve problems, improve processes and make sure products meet the right technical, customer and regulatory standards.

The Role

You’ll support the day-to-day quality needs of the manufacturing team, helping to investigate production issues and make practical, informed decisions about products and processes. A key part of the role will be managing non-conformances, leading root cause investigations and putting corrective actions in place that genuinely prevent issues from happening again.

• Review engineering drawings, specifications, inspection results and CMM reports.
• Support dimensional inspection using equipment such as micrometers, verniers, height gauges and bore gauges.
• Complete product and batch release activities.
• Make sure quality records, documentation and product traceability are accurate and audit-ready.
• Inspect incoming materials and review supplier certificates and supporting documents.
• Work with suppliers to resolve quality or documentation concerns.
• Support internal, customer, supplier and third‑party audits.
• Review quality data, report on trends and KPIs, and contribute to continuous improvement projects.

You’ll already have experience in a Quality Engineer or similar quality‑focused role within a regulated manufacturing environment. You’ll need practical experience of:

• ISO 13485 and manufacturing Quality Management Systems.
• Non-conformance management, CAPA and root cause investigation.
• Product release, traceability, concessions and deviations.
• Reading engineering drawings and technical specifications.
• Dimensional inspection and standard metrology equipment.
• Reviewing CMM inspection reports.
• Supporting audits and maintaining quality procedures and records.
• Analysing quality data and presenting findings clearly.

Medical device manufacturing experience would be ideal, but we’d also be keen to speak with people from precision engineering, aerospace, automotive or rail backgrounds. Experience with ISO 9001, AS9100, ERP or MRP systems, supplier quality, Power BI, Lean, Six Sigma or GMP would be a bonus.

The kind of person who will do well here

You’ll be someone who is comfortable getting involved, asking the right questions and making sensible quality decisions in a busy manufacturing environment. You’ll be practical, proactive and confident working with people across the business. Most importantly, you’ll want to solve problems properly—not just identify them—and help create improvements that last.