Principal Quality Engineer

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. Independently represents the Renal Quality function on Software Product Development teams. Create quality-specific deliverables relating to new product development (e.g., Quality Plan, V&V Plan, etc.). Provides practical direction to team members that create Project Planning, Design Input, Design Output, Verification, Validation and Risk Management deliverables. Actively participate in Design and Technical reviews. Represent the quality function on Product Support Teams. The selected candidate will be a part of strategic Baxter initiative to design, develop and launch new Software Applications into the marketplace. Devises practical approaches to complex problems through adaptations and modifications of standard technical principles. Ability to prioritize assigned tasks based upon project and overall business needs. QUALIFICATIONS: BS or MS in Engineering discipline, BS with minimum of 7 years of experience or M.S. with minimum of 5 years experience in Software Quality Engineering for medical and / or combination devices. Demonstrated practical knowledge of:Â- FDA/ISO regulations governing the development, testing, manufacture, release and support of medical devices; especially software-based medical devices.Â- FDA/ISO regulations surrounding risk management Strong analytical and problem solving skills. Must possess quality assertiveness and independent decision making skills. Demonstrated ability to work effectively within a matrix-managed organization and influence activities without direct functional responsibility. Ability to apply engineering knowledge and independent judgment to technically support the Quality function on a global basis. Excellent verbal and written communication skillsPrevious experience in development of electromechanical devices. Ability to convince management on courses of action with minimal assistance using both written and verbal methods. Desirable:ASQ certification (e.g., CSQE, CQE, etc) and/or Six Sigma Engineering Certificate. 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.