Engr 2, Quality

Shift Schedule: Mon-Friday 3pm-11:30pm


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.

• 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.

• 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.

• 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.

This position is primarily based on the production floor rather than in an office setting. The Quality Engineer is expected to be present where manufacturing occurs, observing processes, responding to issues in real time, and collaborating directly with line personnel to improve quality performance. The role requires standing and walking for extended periods, use of personal protective equipment, and work within controlled manufacturing environments.