Principal Engineer - Quality

Baxter International Inc., assists healthcare professionals and their patients with the treatment of complex medical conditions, including cancer, hemophilia, immune disorders, kidney disease and trauma. The company applies its expertise in medical devices, pharmaceuticals and biotechnology to make a meaningful difference in patients' lives. Provides Quality Engineering support for development of, or changes to Cell Therapies devices in the Bioscience Regenerative Medicine Business unit. Independently represents the Cellular Therapies Quality function on new product development teams. Provides direction and critical reviews for Development Planning, Design Inputs, Design Verification and Validation Testing, Technical reviews and Design Reviews, Risk Management Planning, Risk Analysis / Risk Control, and Risk Management Reporting. Independently represents the Cellular Therapies Quality function on product support teams. Responsibilities include review and analysis of product quality data streams, ensure initiation of investigations, participate in review of product change requests, help evaluate and prioritize issues and initiatives. Works closely with DCOE to design or review method or process validations, process capability, and process control studies for multiple products and processes.Be a resource to DCOE and other departments in structuring of protocols, and verification of study reports. Diversified knowledge of applied Statistical Analysis techniques, procedures. Assure compliance to corporate specifications, SOP's, Good Manufacturing Practices/Quality System Regulations (FDA 21CFR 820), Corporate Quality Manual (CQM), ISO 13485-2003, Canadian Medical Device Requirements (CMDR), MDD 93/42/EEC and other applicable standards and regulations. Must conduct or coordinate defect/failure analysis on product as required. With minimal guidance, schedules and leads a team through the planning and execution of a smaller project or defined piece of a larger project. This includes constructing detailed, accurate project schedules, and interacting with engineering, clinical, operations, and manufacturing groups. QUALIFICATIONS: BS degree in Engineering or Technology or Sciences (ME, IE, CHE, BME, EE, Biology, Chemistry, Physics) Engineering Preferred. Knowledge of statistical applications to Quality Management ASQC Certified (CQE or CRE) desired. Experimental Design and Control Charting experience desired. Project Coordinator experience desired. Experience with electromechanical medical device design and design controls Experience with FDA, TUV, and other regulatory audits Effectively operate in and may facilitate cross-functional teams with guidance. Must be able to provide solutions that reflect understanding business objectives and cost implications. As a global leader dedicated to building the best team in health care, Baxter offers competitive compensation and full benefits. To view other opportunities at Baxter, please visit our Careers@Baxter site. EOE M/F/D/V.