Quality Ops Analyst

Summary

The Quality Ops Analyst 1 is responsible for the day-to-day administration of Illumina’s Quality Assurance programs in support of the company’s Quality Management System. The Quality Ops Analyst 1 will be involved in the development, implementation, and maintenance of Quality System processes to meet the requirements of FDA 21 CFR 820, ISO 13485, and other applicable quality and regulatory standards.

Roles & Responsibilities

• Device History Record Review and Product Release
• Supports Internal/External Quality Audit activities and other key quality initiatives, as appropriate
• Administers and maintains Quality System records

• 1-3 years of experience in medical device Quality Assurance or Manufacturing, applying quality regulations and standards (e.g., 21 CFR 820, ISO 13485).
• Device History Record Review and Product Release experience
• Excellent interpersonal, verbal, and written communication skills
• Excellent attention to detail, well organized and able to work independently and in teams with minimal supervision
• Experience working with complex Quality System Databases and ERP systems. (e.g., SAP, etc)
• Bachelor’s or Associate’s degree in a scientific or technical field; e.g., electrical engineering, mechanical engineering, chemical engineering, biology, etc. or equivalent experience and/or certification

• US Citizen
• Green Card