Job Details

Quality Engineer

Location: Newport News, VA (onsite, 5 days/week)

Step into a critical role at the intersection of quality and innovation. As a Quality Engineer, you'll be embedded in an FDA-regulated, ISO 13485-certified environment where your expertise will drive product excellence and regulatory compliance. Join a team that values precision, collaboration, and continuous improvement.

Why You Should Apply

• Work onsite in a dynamic, highly regulated medical device environment
• Lead investigations for NCRs, SCARs, and CAPAs
• Collaborate across QA, R&D, and Engineering teams
• Drive ISO 13485 compliance and document control systems

What You'll Be Doing

• Investigate nonconformities, manage complaints, and lead root cause analysis
• Revise procedures and maintain document control
• Perform quality data analysis and trending
• Support audits, risk management, and inspection processes
• Collaborate on product and process improvement initiatives

About You

• ISO 13485 QMS experience and FDA-regulated industry background
• Certified Quality Engineer or Auditor (CQE/CQA) preferred
• Strong data analysis and statistical problem-solving skills
• Comfortable interfacing across departments and management levels

We are an equal opportunities employer and welcome applications from all qualified candidates.