Senior Principal Quality Engineer \ Renal Products
McGaw Park, IL
Req ID 50275BR
Business Title
Senior Principal Quality Engineer / Renal Products
Business
Global Quality
Sub-Business
Medical Products Support
Country
US
State/Province
Illinois
Location of Position
McGaw Park - Gr, IL
Shift_
1st
About Baxter
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.
Job Description
•Deals with FDA Quality System Regulations, ISO 13485 , ISO 14971, complaint investigations, CAPA/NC ownership, Design Changes, provides support for audits and inspections, writes technical documentation that may be submitted to a regulatory agency and leads small teams.
•Works with Disposable product development and process development process
•Handles risk management and design control issues.
•Works extensively with cross-functional teams, including technical and non-technical work.
•Coaches and mentors junior engineers on quality system regulations and technical aspects of sustaining released products
•Organizes and presents technical and project management overviews without assistance
•Successfully delivers results on several technical challenges. ***Position will be moving from McGaw Park to Round Lake, IL in 2Q of 2012***
Job Requirements
•Minimum B.S. degree in Engineering ( not in the Electrical/Electronics field)
•8-10 years directly-related quality experience
•Hands-on, demonstrable work experience with: FDA Quality System Regulations, ISO 13485, ISO 14971, complaint investigations, CAPA/NC ownership, Design Changes, providing support for audits and inspections, writing technical documentation that may be submitted to a regulatory agency and leading small teams
•Recognized expert in risk management and design control
•Previous experience in mentoring junior engineers re quality system regulations and the technical aspects of sustaining released products
Doing Work that Matters
Baxter provides its employees with comprehensive compensation and benefits. To view additional opportunities at Baxter and to learn more about the company, please visit our Web site at company website. EOE M/F/D/V.
