Principal Quality Engineer Job in Waukegan 60085, Illinois US
Thursday, August 19th, 2010Baxter International Inc. develops, manufactures and markets products that save and sustain the lives of people with hemophilia, immune disorders, infectious diseases, kidney disease, trauma, and other chronic and acute medical conditions.
As a global, diversified healthcare company, Baxter applies a unique combination of expertise in medical devices, pharmaceuticals and biotechnology to create products that advance patient care worldwide.The Principal Quality Engineer is responsible for supporting and sustaining Renal Quality Engineering activities related to medical device design control and post-market product support for hardware/software systems and associated disposables.
Responsibilities include: * Demonstrate expertise in the areas of Quality Engineering and worldwide Quality System standards and regulations * Generate design plans, review design inputs, outputs, verification, validation and design transfer strategies * Perform Risk Management activities for sustaining engineering projects * Demonstrate assertiveness and be able to independently represent the Quality function in various roles such as product support and lifecycle management * Assist in decision making for process and product improvement efforts * Perform quality-related functions for design changes * Perform quality-related functions for global Renal manufacturing facilities and associated manufacturing and supplier changes * Perform quality-related functions for post market activities such as complaint investigation, complaint trending, CAPA, product Manufacturing Hold, event-related Health Hazard Assessment and Field Corrective Action (recall) processes * Preside as subject matter expert (SME) and participant in compliance audits and FDA/Ministry of Health (MOH) inquiries and inspections * Perform quality-related functions for DHF/risk remediation activities * BS in Engineering/Science and 5-8 years of relevant experience or M.
S and minimum 5 years relevant experience in Quality Engineering for Medical hardware and/or disposables preferred * ASQ (e.
g., CQE, CMQ/OE, etc.) and/or Six Sigma certification highly preferred.
Certification is expected within 2 years of employment * Excellent verbal, written communication skills * Strong analytical and problem solving skills * Demonstrated ability to lead others within project or investigational environmentsBaxter provides its employees with comprehensive compensation and benefits.To view other opportunities at Baxter and to learn more about the company, please visit our Web site at http://www.baxter.com/about_baxter/careers .
EOE M/F/D/V.
Principal Quality Engineer Job in Waukegan 60085, Illinois US