Role: Quality Engineer
Contract# W2 with Medical Benefits
Location: Mebane, NC
Work days/hours: M - F (2nd shift 03:00PM to 11:00PM) and (3rd shift 11:00PM to 07:30AM)
Client: Medical
This Quality Engineer role is an on-the-production-floor position supporting a Class III medical device manufacturing site. The Quality Engineer partners closely with production, manufacturing engineering, and operations leadership to identify quality issues in real time, contain and investigate defects, reduce nonconforming product, and strengthen manufacturing quality processes. This role has a strong daily presence on the production line and is responsible for driving disciplined, compliant, and practical quality improvements that protect product quality, patient safety, and regulatory compliance.
Key Responsibilities:
- Provide daily, hands-on quality engineering support on the production floor for Class III medical device manufacturing operations.
- Monitor in-process manufacturing activities to identify, escalate, and contain quality defects before nonconforming product progresses downstream.
- Partner with operators, supervisors, technicians, and manufacturing engineers to resolve line issues quickly while maintaining compliance with approved procedures and quality requirements.
- Lead or support investigations of nonconforming product, in-process failures, scrap, rework, and recurring quality issues using structured root cause analysis tools.
- Drive corrective and preventive actions that reduce defect rates, improve yield, and prevent recurrence of production quality issues.
- Review production records, inspection results, trend data, and nonconformance information to identify systemic issues and prioritize improvement opportunities.
Required Qualifications:
- Bachelor’s degree in Engineering, Quality, Manufacturing, Biomedical Engineering, Mechanical Engineering, or a related technical discipline.
- Experience in a regulated manufacturing environment, preferably medical device manufacturing.
- Working knowledge of production quality support, nonconformance handling, root cause investigation, CAPA, and continuous improvement methods.
- Understanding of FDA quality system requirements, ISO 13485, and good documentation practices.
- Experience with in-process inspection, sampling plans, manufacturing controls, and defect prevention methods.
- Ability to analyze manufacturing data and use problem-solving tools such as 5 Whys, fishbone diagrams, Pareto analysis, and basic statistical methods.
Preferred Qualifications:
- Experience supporting Class III medical device manufacturing operations.
- Direct experience with production line quality support, material review board activities, and reduction of scrap, rework, and nonconforming product.
- Knowledge of risk management principles, process validation, equipment qualification, and change control in a regulated environment.
- Experience with statistical process control, process capability analysis, and manufacturing quality metrics.
- ASQ Certified Quality Engineer or similar quality certification.
- Experience working cross-functionally with operations, manufacturing engineering, and quality systems teams.
kindly share resume at gaurav@stellarconsulting.com or call me at 678-935-7045 to discuss more!
