Process Control Quality Engineer / 380

Position Description:Since its founding in 1839, B. Braun has built an unparalleled store of knowledge and expertise in delivering innovative healthcare products, medical devices and programs that enhance working processes in hospitals, alternate care settings and medical practices — increasing safety for patients, doctors and nurses. Its 34,000 employees worldwide are proud of their commitment to translating customer needs into products with unmatched quality, superior technology, cost-effectiveness and environmental responsibility. We are currently seeking a Quality EngineerTo qualify for this position, candidates must possess/or meet the following requirements:BS degree in an engineering or scientific discipline with at least three years experience in a Pharmaceutical Quality Control or Engineering position. CQE desired. Demonstrated knowledge within the areas of Industrial Quality Control and Quality Engineering. Expertise in Industrial Statistics and its application to Pharmaceutical Manufacturing and Quality Control. Familiarity with US FDA cGMP. General knowledge of Medical Device (Class II and III) regulation and ISO requirements. Applications software supporting statistical data analysis. Familiarity and understanding of systems related to Quality Control, including Engineering, Chemistry, Microbiology,Sterilization Assurance and Aseptic Manufacturing. Knowledge of Six-Sigma, DOE, DFMEA, FMEA, and FTA. Knowledge and experience of Quality Systems, Nonconformance Handling, CAPA, and Supplier Performance Monitoring. Knowledge and experience of equipment IQ/OQ/PQ and process validation.ESSENTIAL FUNCTIONS:Provide sustaining Quality Engineering support toward the maintenance and improvement of Irvine products, processes, and equipment. Provide technical expertise and specialized knowledge in quality control systems for pharmaceutical manufacturing processes and related products.Interface effectively with management personnel in Engineering, Manufacturing, and other technical disciplines. Provide leadership and technical guidance in the areas of process improvement, quality, and manufacturing control systems. Design and implement improved in-process and statistical control systems for maximum efficiency. Prepare and present technical investigative reports to management. Investigate and formulate recommendations for disposition or other actions related to product nonconformances, process deviations, and field performance issues. Represent Company in contracts with regulatory agencies, including interface with FDA inspectors.B.Braun offers an excellent benefits package, which includes healthcare, a 401(k) plan, company sponsored pension, and tuition reimbursement. To learn more about B. Braun and our safety healthcare products or view a listing of our employment opportunities, please visit us on the internet at www.bbraunusa.com An EOEThrough its “Sharing Expertise®” initiative, B. Braun promotes best practices for continuous improvement of healthcare products and services.