Position Details

Type Full-Time

Experience entry

Exp. Years 1+ years (preferred)

Education Bachelor's degree in Biomedical Engineering, Mechanical Engineering, or Industrial Engineering

Category Engineering (Non-Software)

About this role

Labcorp is seeking a Quality Engineer to join the Burlington facility. The role focuses on validation of equipment/processes/software, document control, and quality system support to improve product reliability and regulatory alignment.

Key Responsibilities

Conduct validations of equipment, processes, and software including validation protocols and reports
Maintain equipment control documentation systems and oversee documentation for facilities, validations, and engineering changes
Create, review, update, and approve SOPs, risk assessments, validation documents, and related quality system materials
Analyze quality metrics and present trends
Investigate quality issues and perform root cause analysis for corrective actions

Technical Overview

Responsibilities include developing validation protocols, maintaining documentation across facilities, creating SOPs and risk assessments, analyzing quality metrics, and conducting root cause analysis to drive corrective actions. Proficiency in Excel/Word/PowerPoint and basic HTML/VBA are beneficial for data handling and reporting.

Ideal Candidate

The ideal candidate is a quality engineer with bachelor's in an engineering discipline, 0-2 years of medical device/FDA-regulated experience, strong analytical skills, and proficiency with Excel/Word/PowerPoint; capable of validation, documentation, and cross-functional collaboration.

Must-Have Skills

Bachelor's degree in Biomedical EngineeringBachelor's degree in Mechanical EngineeringBachelor's degree in Industrial Engineering

Nice-to-Have Skills

1+ years experience in medical device or FDAregulated industries1+ years proficiency in technical writingMicrosoft Office applications including WordExceland PowerPoint

Tools & Platforms

Microsoft WordMicrosoft ExcelMicrosoft PowerPoint

Required Skills

Validation protocolsSOPsrisk assessmentsroot cause analysisdata extractiondata analysisExcelWordPowerPointHTMLVBAsupplier auditssupplier managementFDAregulatedGxPcorrective actionstraining materialsvalidated spreadsheetselectronic formsquality system materialsnonconformancescustomer complaints

Hard Skills

Validationvalidation protocolsvalidation documentsSOPsSOPrisk assessmentsroot cause analysisdata extractiondata analysisExcelMicrosoft ExcelWordMicrosoft WordPowerPointMicrosoft PowerPointHTMLVBAsupplier auditssupplier managementFDAregulatedGxPcorrective actionstraining materialsvalidated spreadsheetselectronic formsquality system materialsnonconformancescustomer complaints

Soft Skills

strong analytical skillsproblem-solvingexcellent verbal and written communicationcollaboration across functionstraining material developmentdata-driven decision makingattention to detailself-motivation

Industry & Role

Industry Healthcare & Medical

Job Function Quality engineer ensuring validation, documentation, and quality system compliance across manufacturing operations.

Role Subtype Quality Engineer

Keywords for Your Resume

Quality EngineerSOPsvalidation protocolsvalidation documentsrisk assessmentsroot cause analysiscorrective actionsdata extractiondata analysisExcelMicrosoft ExcelWordMicrosoft WordPowerPointMicrosoft PowerPointHTMLVBAFDAregulatedGxPsupplier auditssupplier managementvalidated spreadsheetselectronic formslab equipmentquality system materialsnonconformancescustomer complaintsvalidationLabcorpBurlington NCFDAmedical devices

Deal Breakers

Bachelor's degree in engineering required, No experience in medical device or FDAregulated industries, Lack of proficiency in Microsoft Office, Lack of ability to perform root cause analysis, Inability to work on-site in Burlington, NC

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