Quality Assurance Engineer I

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