Quality Engineer II

Position Summary:

Carestream Health is looking for a Manufacturing Quality Engineer to support our manufacturing operations at 1049 West Ridge Road. This position will develop, implement, and improve quality systems, process controls, inspection methods, and corrective actions. This Quality Engineer position is responsible for ensuring products and processes consistently meet customer, regulatory, safety, and quality requirements. They serve as a cross-functional leader, utilizing data analysis and structured problem-solving techniques to identify risks, eliminate defects, and improve process capability. This position ensures compliance with the organization’s Quality Management System and applicable requirements of ISO 13485, ISO 9001, the FDA Quality Management System Regulation, MDSAP, and customer-specific requirements. The position partners closely with Manufacturing, Operations, Supply Chain, Engineering, and Regulatory functions to drive product quality and operational excellence.

Position Responsibilities:

• Provide hands-on quality engineering support for electromechanical assembly, testing, inspection, packaging, and service operations to ensure products and processes meet approved specifications and quality requirements.
• Monitor and analyze product, process, supplier, and service quality performance using statistical methods and key metrics to identify trends, reduce defects, and improve process capability and operational performance.
• Lead investigations of manufacturing defects, nonconforming material, supplier issues, service failures, and customer complaints using structured root-cause analysis, risk assessment, and corrective and preventive action methods.
• Develop and maintain control plans, inspection plans, sampling methods, acceptance criteria, quality procedures, work instructions, investigation reports, and other controlled quality documentation.
• Plan, review, and execute qualification, validation, measurement-system, and change-control activities for manufacturing processes, equipment, software, test methods, inspection systems, products, and materials.
• Support supplier qualification and improvement, internal and external audits, quality-system compliance, employee training, and cross-functional initiatives that ensure continued conformance with applicable regulatory, customer, and company requirements.

Required Skills & Education:

• Bachelor’s degree in quality, mechanical, electrical, industrial, manufacturing, biomedical, or a related engineering discipline.
• 2+ years of quality engineering experience in a regulated manufacturing environment.
• Working knowledge of ISO 13485 and experience applying quality-system, documentation, risk-management, and regulatory requirements within a manufacturing environment.
• Demonstrated experience investigating product and process nonconformities, leading structured root-cause analysis, and implementing sustainable corrective and preventive actions.
• Experience analyzing manufacturing data and developing process controls, inspection plans, acceptance criteria, validation documentation, or other manufacturing quality records.
• Strong analytical, project-management, written, and verbal communication skills.

Desired Skills:

• Experience in medical-device, diagnostic-equipment, radiographic-imaging, or another FDA-regulated manufacturing environment.
• Experience supporting electromechanical assembly, system-level testing, troubleshooting, returned-product analysis, installation, or service operations.
• Knowledge of ISO 9001, the FDA Quality Management System Regulation, Medical Device Single Audit Program requirements, and medical-device risk-management principles.
• Experience with process validation, equipment qualification, test-method validation, measurement-system analysis, statistical process control, process capability analysis, or design of experiments.
• Experience with supplier qualification, supplier audits, supplier corrective actions, statistical-analysis software, enterprise resource planning systems, or electronic quality-management systems.
• American Society for Quality Certified Quality Engineer, Lean Six Sigma Green Belt or Black Belt, or ISO 13485 or ISO 9001 auditor certification or training is preferred.

Work Environment:

Manufacturing, Labs and Offices

Physical Requirements:

• Standing: 50-75%                                               
• Walking: 25-50%
• Sitting: 1-25%
• Bending: 25-50%
• Carrying, Pushing or Pulling: 25-50%
• Lifting 20-35 pounds: 1-25%
• Lifting 35-50 pounds: 1-25%
• Lifting 50-100 pounds: 0%