Baxter 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 Senior Principal Engineer is responsible for supporting and sustaining Renal Quality Engineering activities related to medical device disposables and/or hardware..
Responsibilities include:
? Mentor others in the areas of Quality Engineering and Quality System regulations.
? Provide leadership role in generating Design Plans, reviewing design inputs, outputs, verification, validation and design transfer strategies.
? Lead Risk Management activities for sustaining engineering projects.
? Demonstrate quality 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 improvement efforts
? Support post market activities such as complaint investigation, complaint trending, CAPA, and FCA processes
? Support global Renal manufacturing facilities and associated manufacturing and supplier changes
? Preside as subject matter expert (SME) and key participant in compliance audits and FDA/ministry of health (MOH) inquiries
? Provide Quality input to DHF/risk remediation activities
? B.S. in Engineering and minimum 10 years of relevant experience preferred, OR
? M.S. and minimum 8 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
? Excellent verbal, written communication skills.
? Strong analytical and problem solving skills
? Demonstrated ability to lead others within project or investigational environments
Baxter 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.
