Quality Assurance Engineer I

Job Summary

To support quality engineering initiatives, the full-time Quality Assurance Engineer I will investigate and analyze quality complaints, ensuring compliance with regulatory standards while working in a hybrid environment.

Key responsibilities

• Investigate and review quality complaints, determining risk levels and root causes
• Analyze data from various quality inputs to identify trends and systemic issues
• Develop and implement corrective actions and continuous improvement strategies for quality performance

Required qualifications

• Bachelor's degree in Engineering
• 1-3 years of experience in the medical device industry
• Knowledge of 21CFR820 and FDA cGMP regulations
• Experience with statistical software packages, preferably Minitab
• Strong analytical skills with a focus on root cause investigations