Title: Quality Operations Specialist I
Location: Irvine CA
Duration: 12+ Months

Pay Range: $33.22/hr - $35.48/hr

• Review and investigate assigned technical and clinical customer complaints.
• Perform hands-on technical investigations and document results per established procedures and timelines.
• Performs hands-on troubleshooting of customer returned devices and manufacturing nonconformities and completes associated technical documentation
• Assist complaint intake group through review and verification of initial complaint coding.
• Monitor post-market and manufacturing product performance through evaluation and trending of customer complaints, service calls, and manufacturing rejections.
• Ensure that appropriate corrective actions are implemented to address the root cause of trending issues.
• Supports quality functions pertaining to manufacturing line support and maintenance, including SAP.
• Support and coordinate product/process improvements through collaboration with cross-functional teams (Quality, Manufacturing, R&D, Supply Chain, Finance, etc.).
• Ensure compliance with the company’s Quality System policies and procedures and applicable external requirements and standards, including FDA, ISO 13485, and other worldwide regulatory agencies pertaining to medical devices

MINIMUM REQUIREMENTS:

Bachelor’s Degree - Mechanical Engineering OR Electrical Engineering Degree with Optical/Ophthalmic Device Experience
Years’ Experience: 0-2 years

Please refer the Job description for details