Quality Engineer I

Facilitate and maintain validation project documentation, including the Site Validation Master Plan, while collaborating with customers on equipment and process validations. Serve as a database administrator for Infinity QS software and provide statistical analysis support for manufacturing, new product development, trials, and validations. Develop SOPs related to validation and risk management, monitor and prepare Key Performance Indicators (KPIs) for major customers, and lead Corrective Action/Preventative Action (CAPA) activities with root cause investigations. Train associates on quality topics such as SPC and CAPA, and drive continuous improvement initiatives with internal teams and external partners. This role requires a Bachelor's degree in Engineering or Science with 3+ years of experience in FDA-regulated environments, preferably in nutritional products, medical devices, or pharmaceuticals.