Quality engineers(imaging device)

We are seeking an experienced Quality Engineer to support a high-volume medical device manufacturing environment. This role will work directly with production and manufacturing engineering teams to investigate quality issues, support manufacturing operations, and drive continuous improvement initiatives.

The ideal candidate will have strong hands-on experience troubleshooting electromechanical medical devices and a solid background in manufacturing quality within the medical device industry.

Key Responsibilities

• Support production lines and manufacturing operations to ensure product quality and compliance.
• Conduct Non-Conformance Event (NCE/NC) investigations and containment activities.
• Perform risk assessments and quality impact evaluations.
• Develop and execute rework procedures and corrective actions.
• Review Device History Records (DHRs) for accuracy and compliance.
• Collaborate with Manufacturing Engineering, Production, and Quality teams to resolve product and process issues.
• Drive CAPA activities and support continuous improvement initiatives.
• Troubleshoot electromechanical devices and identify root causes of quality issues.

Required Qualifications

• Bachelor's degree in Mechanical Engineering or a related engineering discipline.
• Experience as a Quality Engineer within the Medical Device industry.
• Strong hands-on troubleshooting experience with electromechanical devices.
• Experience supporting manufacturing and production environments.
• Knowledge of:
• NCE/NC Investigations
• CAPA Processes
• Risk Assessments
• Device History Record (DHR) Reviews
• Rework Activities
• Manufacturing Quality Systems

Preferred Qualifications

• Experience with medical imaging systems or devices, including:
• X-Ray Systems
• CT Scanners
• MRI Systems
• Ultrasound Equipment
• Fluoroscopy Systems
• Previous experience supporting complex medical device manufacturing operations.