Quality Engineer - Onsite (Urgent Need)

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.
• Support material review, nonconformance documentation, product disposition, deviation assessment, and implementation of containment actions.
• Train and coach production personnel on defect awareness, inspection expectations, good documentation practices, and quality standards.
• Act as the quality voice on the floor, helping balance production output with product quality, compliance, and patient safety.

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.
• Strong communication skills and the ability to work effectively with production associates, supervisors, engineers, and quality personnel.
• Ability to make sound quality decisions in a fast-paced manufacturing environment.
• Willingness and ability to spend substantial time on the production floor each day.

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.