Sr Engineer, Quality

The Senior Quality Engineer provides engineering support to the plant through process optimization, risk management, validation, defect prevention, project management, and technical evaluations. This role ensures compliance with GMP/QSRs and all applicable standards related to product/process validation. This role may lead project-based individual contributors / contractors or mentor newer Quality Engineers as needed. The job contributes to engineering and technical expertise through the Quality function to the manufacturing facility. Baxter is focused on saving and sustaining lives by manufacturing high-quality products. We strive to create quality products for our customers each day. Delivering life-saving products is about getting them right, and attention to detail is how we make sure we meet that challenge. We are a team that supports each other throughout each shift. Working together in a supportive and open culture makes our processes evolve for the better and engages our workforce. Leads or assists in developing and implementing new machines/processes/computer systems and in improvements to existing methods. Requirements for new/improved machines/processes/computer systems, including system requirements/ design specification, risk analysis; installation qualification, operational qualifications, and performance qualification are all in the scope of the Quality Engineer. This requires interfacing with local Quality, Production, and Engineering as well as Corporate Engineering, Quality, and Regulatory functions. Supports the manufacturing plant through implementation of process improvements. Conducts process/financial analysis through conventional methods of ROI, quality trending/tools, MIP measurements and implements/drives improvements. Manage small projects (both new and improvement) to include cost, change management, implementation, and validation. Leads cross-functional teams. Leads ongoing validation and verification programs such as Continuous Process Verification (CPV), Validation Master Plans, Periodic Reviews, Computer Systems Validation, Stability program and Calibration. Perform statistical analysis to support Quality and Production. Evaluates sampling/ testing/ qualification plans with respect to current quality levels and test methods. Accountable for the testing required in conjunction with protocols, in-process risk assessment, and situation appraisal. Composes protocols, final reports, studies, experiments and general information reports for use by management. Routes documents in the Document Management System. Leads/coordinates validation efforts of new equipment and changes to existing equipment. Assure compliance of manufacturing and quality control operations with respect to corporate specifications, SOP’s, Good Manufacturing Practices/Quality System Regulations (FDA 21CFR 210-211,820), Corporate Quality Manual (CQM), ISO 13485-2003, and other applicable standards and regulations.