Quality Engineer

Job Summary

To support quality initiatives, the contract Quality Engineer will investigate and analyze complaint issues, review service data for risk assessment, and drive continuous improvement activities in a hybrid role based in Skaneateles, NY.

Key responsibilities

• Conduct investigations into quality complaints and analyze data to identify trends and systemic issues
• Develop strategies to address gaps in GMP compliance and implement corrective actions
• Lead corrective and preventive actions in manufacturing while supporting CAPA and maintenance activities for existing product lines

Required qualifications

• Bachelor of Science degree in Engineering
• 1-3 years of experience in the Medical Device industry
• Knowledge of 21CFR820 and FDA cGMP requirements
• Experience with statistical software packages, preferably Minitab
• Strong analytical skills for root cause investigations and problem-solving