Quality Engineer
Mohammed (Zack Cooper) H.United StatesJUNIORPosted 2h ago
About the Role
We are looking for a detail-oriented Quality Engineer to support medical device quality, compliance, and product excellence.
Key Responsibilities
• Support medical device quality, compliance, and product excellence
• Perform root cause analysis, statistical techniques, and inspection methods
• Ensure adherence to ISO 13485, FDA QSR (21 CFR 820), and ISO 14971 standards
Requirements
• 0–5 years of experience in Medical Device QA/QE
• Bachelor’s or Master’s in Mechanical Engineering, Biomedical Engineering, or a related scientific field
• Medical device quality assurance or quality engineering experience
• Spine device experience
• Knowledge of root cause analysis, statistical techniques, and inspection methods
• Familiarity with ISO 13485, FDA QSR (21 CFR 820), and ISO 14971 preferred