Quality Engineer

Labcorp • Burlington, NC

14d • Onsite

About The Position

MEDTOX® Diagnostics, part of Labcorp’s Diagnostic Devices Group, is a manufacturer of FDA 510(k)-cleared in vitro medical devices, including drugs‑of‑abuse testing devices and rapid men’s fertility tests. With more than three decades of experience producing millions of devices annually, MEDTOX is an established leader in diagnostic testing. The Quality Engineer supports equipment integrity, process compliance, and quality system performance across manufacturing operations. The role conducts validations, evaluates quality data, investigates issues, and drives continuous improvement, working cross‑functionally to ensure product reliability and regulatory alignment.

Requirements

• Bachelor’s degree in an engineering discipline such as biomedical, mechanical, or industrial engineering.
• Strong analytical and problem‑solving skills.
• Excellent verbal and written communication abilities.
• Ability to collaborate across functions to support product implementation and troubleshooting.

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.
• Experience with computer programming such as HTML or VBA.
• Experience with graphic design or photo editing.

Responsibilities

• Conduct validations of new, upgraded, and existing equipment, processes, and software, including creation of 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 such as customer complaints, nonconformances, and equipment failures, and present trends.
• Investigate quality issues and perform root cause analysis to support corrective actions.
• Extract, clean, analyze, and summarize data to address product and process performance issues and support improvement initiatives.
• Participate in supplier audits and supplier management activities.
• Support internal projects including new product introductions and process improvement initiatives.
• Assist in creating training materials, electronic forms, and validated spreadsheets for manufacturing and inspection workflows.

Benefits

• Employees regularly scheduled to work 20 or more hours per week are eligible for comprehensive benefits including: Medical, Dental, Vision, Life, STD/LTD, 401(k), Paid Time Off (PTO) or Flexible Time Off (FTO), Tuition Reimbursement and Employee Stock Purchase Plan.
• Employees regularly scheduled to work less than 20 hours, Casual, Intern, and Temporary employees are only eligible to participate in the 401(k) Plan.
• Employees who are regularly scheduled to work a 7 on/7 off schedule are eligible to receive all the foregoing benefits except PTO or FTO.

What This Job Offers

• Job Type: Full-time
• Career Level: Entry Level
• Number of Employees: 1-10 employees