MEDTOX® Diagnostics, a member of Labcorp's Diagnostic Devices Group, is a leader in the manufacturing of in vitro medical devices. Founded in 1987, MEDTOX manufactures FDA 510(k)-cleared drugs of abuse testing devices and men’s rapid fertility test devices. With over 30 years of expertise and manufacturing more than 3 million devices annually, MEDTOX is a trusted name in diagnostic testing.
Job Summary
The Quality Engineer is responsible for ensuring the integrity of equipment, processes, and quality systems by performing equipment validations, analyzing quality data, investigating quality issues, and driving continuous improvement efforts. This role collaborates across departments to support product implementation, troubleshoot issues, and maintain compliance with the quality management system.
Key Responsibilities
-
Conduct validations of new, upgraded, and existing equipment, processes, and software, including preparing protocols and reports.
-
Manage equipment control documentation systems and ensure proper documentation for facilities, validations, and engineering changes.
-
Create, update, review, and approve SOPs, risk assessments, validation protocols, and related documents.
-
Analyze quality metrics, including customer complaints, nonconformances, and equipment failures, and present trend analyses.
-
Investigate quality issues and perform root cause analyses for corrective actions.
-
Extract, clean, analyze, and present data to address product/process performance issues and support improvement initiatives.
-
Participate in supplier audits and supplier management processes.
-
Lead or contribute to internal projects for new product introductions and process improvements.
-
Assist in developing training materials, electronic forms, and validated spreadsheets for manufacturing and inspection processes.
Qualifications
-
Education: Bachelor’s degree required, preferably in an engineering discipline (e.g., biomedical, mechanical, or industrial).
-
Experience:
-
Experience in medical device or FDA-regulated industries, quality systems/assurance, or quality control is strongly preferred.
-
Proficiency in technical writing and Microsoft Office applications (Word, Excel, PowerPoint) is required.
-
Experience in computer programming (HTML, VBA), graphic design, or photo editing is a plus.
-
-
Skills:
-
Excellent verbal and written communication skills.
-
Strong analytical and problem-solving abilities.
-
Location: 1238 Anthony Rd, Burlington, NC
Schedule: 8:00 AM - 5:00 PM, Monday - Friday
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. Casual, PRN & Part Time employees regularly scheduled to work less than 20 hours are eligible to participate in the 401(k) Plan only. For more detailed information, please click here.
Labcorp is proud to be an Equal Opportunity Employer:
As an EOE/AA employer, Labcorp strives for diversity and inclusion in the workforce and does not tolerate harassment or discrimination of any kind. We make employment decisions based on the needs of our business and the qualifications of the individual and do not discriminate based upon race, religion, color, national origin, gender (including pregnancy or other medical conditions/needs), family or parental status, marital, civil union or domestic partnership status, sexual orientation, gender identity, gender expression, personal appearance, age, veteran status, disability, genetic information, or any other legally protected characteristic. Additionally, all qualified applicants with arrest or conviction records will be considered for employment in accordance with applicable law.
We encourage all to apply
If you are an individual with a disability who needs assistance using our online tools to search and apply for jobs, or needs an accommodation, please visit our accessibility site or contact us at Labcorp Accessibility.
For more information about how we collect and store your personal data, please see our Privacy Statement.
Top Skills
What We Do
We believe in harnessing science for human good. And so we work day and night, around the world, to deliver answers for all your health questions—whether you’re a provider, drug developer, hospital, medical researcher or patient. That means everything from advancing diagnostic testing to helping launch new drugs, to offering new perspectives through data - all drawing from a deep well of scientific expertise. So when you need trusted information to make clear, confident health decisions, consider us your source.
