Principal\Quality Systems Engineer
Round Lake, IL
Req ID 48919BR
Business Title
Principal/Quality Systems Engineer
Business
Global Quality
Sub-Business
Medical Products Support
Country
US
State/Province
Illinois
Location of Position
Round Lake, IL
Shift_
1st
Job Description
•Knowledge and maintenance of pertinent standards including but not limited to: 21 CFR
•Part 820, ISO9001:2000, Medical Device Directive, ISO13485:2003, Canadian Medical
•Device Regulation.
•Provides guidance and support with regard to GMP concerns.
•Identify and solves basic and complex problems, including the development of new design Experiments and protocols, without assistance.
•Devises new approaches to complex problems through adaptations and modifications of standard technical principles.
•May be responsible for managing project budget(s).
•Implementing and maintaining systems for monitoring compliance of the quality system.
•Performs trend analysis of applicable product or system data. May provide direction or guidance based on analysis results.
•Ability to manage Quality Systems/Compliance plans and projects without assistance. This includes constructing detailed, accurate project schedules, interfacing with development groups and technical support groups in solving project problems, and having the ability to prioritize multiple projects and tasks.
Job Requirements
•Display a solid understanding of theories/practices utilized by other disciplines outside primary area of expertise.
•Ability to convince management on courses of action with minimal assistance using both written and verbal methods.
•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.
•Must be able to effectively communicate and influence others through written and verbal methods.
•Six Sigma Green Belt Preferred
•B.S. in Engineering (Mechanical or Industrial Engineering preferred) and 5 - 8 years related experience, or M.S. and 2- 4 years related experience. Ph.D. 1 - 2 years experience.
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.
