Quality Engineer

Quality Engineer
Nexxt Spine LLC, Noblesville, IN

Nexxt Spine LLC, a leader in the medical device industry, is seeking an accomplished Engineer to focus on quality and process improvements. We design, manufacture, and distribute an expanding portfolio of cutting-edge spinal implants and instruments, and we are committed to fostering a culture of innovation, excellence, and employee engagement.

Position Summary:

Reporting to the Quality Director, the Quality Engineer will analyze and improve manufacturing and industrial processes to improve quality, efficiency and reduce costs. This includes process design, troubleshooting, process optimization, process analysis, process documentation, quality control, project management, process automation and quality assurance. The position will also collaborate with cross-functional teams, implement process improvement initiatives and contribute to the overall success of the organization.

Essential Job Functions:

• Design and implement manufacturing process optimization strategies to enhance efficiency, safety, reduce cycle time and improve product quality.
• Identify and implement process improvements to reduce costs, minimize waste and increase efficiency. Conduct detailed analysis and evaluation of existing manufacturing processes, identify areas for improvement and recommend appropriate solutions.
• Collaborate with engineering, production and quality assurance teams to develop and implement standard operating procedures (SOPs), work instructions and ensure smooth integration of new processes, technologies and equipment. Participate in cross-functional teams to drive root cause analysis, corrective actions and preventive measures.
• Monitor and analyze process performance metrics and data, such as cycle time, yield and scrap rate, and develop strategies to meet or exceed production targets.  Identify trends through statistical analysis and capability studies to propose solutions for continuous process improvement.
• Ensure compliance with safety, environmental and regulatory requirements in all process engineering activities.
• Identify and implement process control measures, including statistical process control (SPC) techniques, to ensure consistent quality and reduce process variation.
• Provide technical support and troubleshooting expertise to resolve process-related issues and improve overall equipment effectiveness (OEE).
• Lead process validation activities, including protocol development, execution and documentation, ensuring compliance with regulatory requirements.
• Provide training and guidance to production teams on new processes, procedures and equipment to ensure successful implementation and operation.
• Stay up-to-date with the latest advancements in process engineering technologies, methodologies and best practices.

Qualifications:

• Bachelor’s degree in Engineering (Process or Quality Engineering preferred.)
• 2+ years of experience as a process engineer in a manufacturing environment, experience in medical device manufacturing preferred.
• Strong knowledge of process optimization techniques, lean manufacturing principles, Six Sigma methodologies and statistical analysis.