You will define quality requirements for new products and preparing/maintaining vital documentation, monitor production and Fabrication quality performance to identify opportunities for improvement, review and maintenance of quality files, procedures, work instructions, etc. for relevance and adherence to the Quality System, customer, and regulatory compliance. Proficient with structured methodologies including but limited to Good Engineering Practices, Quality by Design, Design Space, & Process Control Strategies to be employed during industrial process design, validation, and control.