Quality Engineer

Job Description

• Fully onsite and must be a US Citizen
• Bachelor’s degree in Engineering, Quality Assurance, or a related discipline.
• Minimum of 1+ year of experience in medical device quality assurance.
• Working knowledge of ISO 13485, FDA regulations (21 CFR Part 820), and QMS requirements for Class I, II, and III medical devices.
• Strong understanding of ISO 14971 Risk Management principles.