Senior Engineer
Round Lake, IL
Req ID 50866BR
Business Title
Senior Engineer
Business
Global Quality
Sub-Business
Medical Products Support
Country
US
State/Province
Illinois
Location of Position
Round Lake, IL
Shift_
1st
Job Description
Provide Quality Oversight to Sustaining Product teams in areas of responsibility.
Analyze data from various quality inputs (including, but not limited to: nonconformance, Field Corrective Action, complaints, Medical Device Reports) to determine trends and systemic issues. Prepare and issue reports based on the analysis.
Identify areas for product and systems improvement, and interface with plant and corporate groups to assure improvements are implemented. Develop and revise SOPs to support improvement efforts.
Lead projects for improvements to the quality system as approved by management.
Support CAPA and maintenance activities for existing product lines.
Review and approve new and revised records for the Quality function, including CAPA, Design Change, End of Life, etc.
Provide training/guidance to Quality and Engineering personnel regarding compliance and statistical/analytical tools.
Job Requirements
•Display a solid understanding of theories/practices utilized by other disciplines outside primary area of expertise.
•Demonstrated ability to convince management regarding courses of action with minimal assistance, both in writing and verbally.
•Effectively operate in and facilitate cross-functional teams without guidance.
•Ability to provide solutions that reflect an understanding of business objectives and cost implicatrions.
•Knowledge of FDA, ISO and MDD Regulations.
•Project Management and organizational skills.
•Demonstrated knowledge of problem solving and statistical analysis tools.
•ASQ CQE preferred. BS in Engineering or Physical Science with 5-8 years related experience, or MS and 2-4 years of related experience. Minimum 3 years Quality experience in a regulated environment.
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.
