Product Quality Engineer - Robot

Job description

Job responsibilities

• Oversee product quality during all stages of production and field service.
• Ensure compliance with Good Manufacturing Practices (GMP) regulations and internal quality management systems throughout the manufacturing process.
• Lead and support investigations into nonconforming materials and products (NCRs), working closely with cross-functional teams including Manufacturing and Engineering, identifying root causes, ensuring timely…
• Conduct Material Review Board and participate in materials decision making.
• Establish, implement, and support processes for field service and rework of robotic medical devices.
• Maintain Device History Records for robotic medical devices
• Support creation of risk management files, including the development of Process FMEA
• Lead and support process validation activities, including IQ/OQ/PQ (Installation Qualification/Operational Qualification/Performance Qualification), for new and existing manufacturing processes.

Job requirements

• Bachelor's degree in Engineering or a related technical field. Master's degree is a plus.
• Minimum of 5 years of experience in a manufacturing quality engineering role within the medical device industry supporting electromechanical capital devices.
• In-depth knowledge of FDA regulations, ISO 13485, IEC 60601-1, and other relevant quality & safety standards for robotic medical devices.
• Experience with nonconforming material investigations and implementing effective CAPAs.
• Ability to work in a fast-paced environment