Supplier Quality Engineer

Labcorp•Burlington, NC

1d•Onsite

About The Position

The Supplier Quality Engineer supports the quality and reliability of materials and services provided by external suppliers through supplier qualifications and audits, analysis of supplier quality data, investigation of supplier-related quality issues, and management of supplier-related changes. The role collaborates with suppliers and internal stakeholders to mitigate supply chain risks and drive continuous improvement efforts while maintaining product quality and regulatory compliance.

Requirements

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

Nice To Haves

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.

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.