Principal QAE

Principal Quality Assurance Engineer, Medical Devices QAE
Charlottesville, VA 22911 – Hybrid
 
Lead Quality. Solve Complex Problems. Shape Better Medical Devices.
 
We’re seeking a Principal Quality Assurance Engineer to join our Quality Assurance/Regulatory Affairs team as a technical leader and subject matter expert.
 
This is a hands-on leadership role supporting both new product development and existing medical devices, with a strong focus on quality systems, regulatory compliance, risk management, and continuous improvement.
 
WHAT YOU’LL LEAD:

• Design Controls & New Product Development
• CAPA & Customer Complaints
• MRB/NCMRs & Nonconformance
• Supplier Quality
• Process, Equipment & Test Method Validation — IQ/OQ/PQ
• Risk Management & Design Verification/Validation
• Quality Metrics & Process Improvement
• Internal Audits
• Statistical Analysis, Process Capability & Gauge R&R
• Cross-functional quality investigations

 
WHAT YOU’LL DO:

• You’ll serve as the technical voice for Quality, partnering with engineering, manufacturing, suppliers, customers, and internal teams to identify quality requirements and solve complex mechanical and technical problems

You’ll also:

• Lead and mentor Quality Assurance Engineers
• Drive QAE projects and quality initiatives
• Support design transfer and product/process changes
• Lead complaint investigations and CAPA activities
• Evaluate nonconforming materials and corrective actions
• Partner with suppliers to improve quality, cost, and delivery
• Support customers and sales with technical product concerns

 
WHAT WE’RE LOOKING FOR:

• Bachelor’s degree in Engineering or related field
• At least 8+ years of Quality Assurance/Quality Engineering experience in medical device manufacturing
• Experience with mechanical and electrical products
• ASQ Certified Quality Engineer (CQE) or equivalent required
• Strong knowledge of quality systems, design controls, risk management, CAPA, validation, and regulatory requirements
• Lean Six Sigma experience preferred
• Strong technical problem-solving and cross-functional leadership skills

 
WHY THIS ROLE MATTERS:
This is an opportunity to be more than a quality engineer—you’ll be a technical expert and mentor helping shape the quality, reliability, and compliance of medical devices that impact patients.

• Department: Quality Assurance / Regulatory Affairs
• Reports: No direct reports; serves as a technical expert and mentor

 
Interested? Apply today or message me directly to learn more.
 
We are an equal opportunity employer, and we are an organization that values diversity. We welcome applications from all qualified candidates, including minorities and persons with disabilities.
 
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