Process Eng - P1 May execute the following resposibilities:Identify Manufacturing process defects (scrap, nonconforming material, customer complaints) by dispositioning non-conforming material, assisting in identification of primary root causes and understanding corrective and preventative actions. May be responsible for working with process owner to bound product stops and document release criteria. Understanding of product quality plans, documents and systems by reviewing product specifications, quality specifications, and working with quality systems. May be responsible for learning risk analyses and FMEAs. Monitoring Systems by becoming familiar with systems applications and critical process steps; and through familiarization with methods used to reduce process variation. Becomes familiar with Product/Process improvement efforts by understanding current quality metric data and learning the various analysis methods used to enhance sustaining product design and new product development. Learns Quality Tools & Training Materials by gaining knowledge of prevalent tools used and by reviewing & utilizing available training materials. Checks and provides support in the execution and investigation of CAPAs, NCEP, Failure Mode Investigations, etc. Actively participates in the transfer of new products. Get involved in various stages of equipment and processes validations: Run and/or review and approve reports: TMVs, I.Q 's, O.Q's and P.Q's as well as any other document relating to validation. Read and interpret technical drawings, procedures, and protocols. In all actions, demonstrates a primary commitment to patient safety and product quality by maintaining compliance to the Quality Policy and all other documented quality processes and procedures. Bachelor's degree in chemical, Industrial, Electronic, Biotechnology, Electromechanical Engineering or Related Field English Level required: B2 (70% - 79%). Desired knowledge: process & product validation is desired as well as thorough understanding of inspection techniques and statistical methods, Scientific tools (e.g. Gage R&R, DOE, process capability).