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.
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.
req26-00568
Numbers & Facts
Location
Charlottesville, VA
Salary
$112–$136 Per Year
Skills
Continuous Improvementunmatched
Corrective Actionunmatched
Corrective and Preventative Action (CAPA) Systemsunmatched
Cross-Functionalunmatched
Customer Support/Serviceunmatched
Design Verificationunmatched
Diversityunmatched
Electricityunmatched
Engineeringunmatched
Insurance Regulationsunmatched
Internal Auditunmatched
Leadershipunmatched
Lean Six Sigmaunmatched
Maintain Complianceunmatched
Manufacturingunmatched
Materials Testingunmatched
Medical Equipmentunmatched
Mentoringunmatched
Problem Solving Skillsunmatched
Process Capabilityunmatched
Process Improvementunmatched
Process Validationunmatched
Product Designunmatched
Product Developmentunmatched
Product Supportunmatched
Quality Assuranceunmatched
Quality Assurance Methodologyunmatched
Quality Engineeringunmatched
Quality Managementunmatched
Quality Metricsunmatched
Regulatory Requirementsunmatched
Requirements Validation/Verificationunmatched
Risk Managementunmatched
Statisticsunmatched
Technical Leadershipunmatched
Technical Salesunmatched
Validation Testingunmatched
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