Supplier Quality Engineer

Labcorp is seeking a Supplier Quality Engineer to join our team at our 1238 Anthony Road location in Burlington, NC!

Location: Burlington, NC

Work Schedule: This is a full-time, exempt (salaried) position assigned to a First Shift schedule, with standard business hours of Monday through Friday, 8:00 a.m. to 5:00 p.m. EST.

Business needs may occasionally require flexibility in work hours, including earlier, later, or additional hours, with reasonable notice provided when possible.

Job Responsibilities

• Lead supplier qualification activities, including both initial qualification and requalification following changes in materials/services provided, to ensure conformance to applicable company and regulatory requirements.
• Review supplier-driven changes to determine impacts on product/processes and identify next steps.
• Lead or contribute to change management and verification/validation activities related to supplier changes to ensure no adverse impact on product quality.
• Conduct supplier audits and oversee corrective action processes.
• Extract, clean, analyze, and summarize supplier performance data, including inspection results and material nonconformances, to support ongoing supplier assessments and drive continuous improvement.
• Develop and maintain supplier quality agreements that ensure alignment with regulatory expectations.
• Develop and maintain purchase specifications as necessary to communicate requirements to suppliers.
• Develop and maintain inspection plans for purchased components.
• Investigate supplier-related nonconformances, ensure implementation of corrective and preventive actions (CAPA), and verify effectiveness.
• Provide guidance to suppliers on product quality expectations and relevant regulatory requirements.
• Collaborate with cross-functional teams (Quality Systems, Design & Development, Purchasing, Operations, and Regulatory Affairs) to support transfer of new product designs into manufacturing.
• Participate in risk management activities related to supplier-provided components and services.
• Ensure proper documentation and traceability of supplier records in compliance with quality management system (QMS) requirements.
• Crosstrain and assist with other quality engineering activities, such as engineering changes, risk assessments, process validations, quality issue investigations, development and maintenance of quality related documentation, .
• Support internal and external audits, including FDA inspections and ISO certification audits.

• Bachelor's degree in an engineering discipline such as biomedical, mechanical, or industrial engineering.

• 1 or more years of experience in medical device or FDA-regulated industries, quality systems, quality assurance, or quality control.
• 1 or more years proficiency in technical writing and Microsoft Office applications including Word, Excel, and PowerPoint.

• Strong analytical and problem-solving skills.
• Excellent verbal and written communication abilities.
• Ability to collaborate across functions to support product implementation and troubleshooting.
• Well organized with high attention to detail.