Quality Engineer I

Baxter International Inc.•Cleveland, MS

5d•$76,000 - $95,000

About The Position

As a Quality Engineer I at Baxter Healthcare Corporation, you will help ensure the quality and reliability of healthcare products. The role supports quality and manufacturing operations through validation, process capability and control studies, application of statistical analysis, and the development and implementation of processes and technology. It also involves validating computer systems and facility systems against regulatory quality standards, supporting compliance with FDA regulations, and coordinating project testing and changes to applications. The work contributes to patient health and well-being and is performed in accordance with quality, cGMP, environmental health and safety, and 6S requirements.

Requirements

Bachelor of Science degree in Engineering, Computer Science, or another core science field.
0–1 year of related experience, which may be in-house, co-op, or acquired outside the company.
Meet visual acuity requirements detailed in the Baxter Cleveland Visual Acuity Procedure CL-01-01-037.
Ability to lift up to 10 pounds.
Ability to sit, stand, and/or walk for long periods.
Ability to reach above the shoulder.
Ability to bend or stoop.
Authorized to work for any employer in the United States; visa sponsorship or transfer is not available.

Nice To Haves

Knowledge of Wonderware, Allen-Bradley PLC, Access, and Microsoft Project.
ASQ certification (CQE or CSQE) or equivalent.
Strong leadership skills and ability to work with diverse cross-functional teams across different plant locations.
Logical thought process and self-motivation to work well without direct supervision.
Ability to quickly learn and understand applications.
Experience in Quality Assurance or the pharmaceutical industry.

Responsibilities

Perform process validation, process capability, and process control studies for assigned areas.
Drive quality and manufacturing projects using Lean, problem-solving, process control, and project management tools to achieve and sustain operational excellence.
Support Manufacturing, Engineering, and Quality Management departments with developing and implementing new processes and technology.
Help identify and develop process improvement projects, including automation and computerization.
Validate computer systems and applications to ensure alignment with regulatory quality standards.
Ensure FDA regulations are met for system upgrades and replacements.
Write and complete protocols and test cases for facility system validations, coordinate testing and project details, implement application changes, and assist with systems training.
Apply statistical analysis techniques to measurements and process and product capability studies supporting development or refinement of equipment, materials, processes, instruments, and products.
Communicate effectively in writing and verbally and function as a team member.
Follow plant and department environmental health and safety regulations.
Learn, understand, and apply quality standards, established guidelines, and current Good Manufacturing Practices (cGMP).
Notify the supervisor and take appropriate action when safety, quality, mechanical, or discrepancy issues occur.
Maintain a clean and safe work area using 6S principles.
Perform other duties and responsibilities as assigned by supervision or management.

Benefits

Medical and dental coverage beginning on day one for eligible roles.
Basic life, accident, short-term and long-term disability, and business travel accident insurance.
Employee Stock Purchase Plan with the ability to purchase company stock at a discount.
401(k) Retirement Savings Plan with employee contribution options and company matching.
Flexible Spending Accounts.
Educational assistance programs.
Paid holidays.
Paid time off ranging from 20 to 35 days based on length of service.
Family and medical leaves of absence.
Paid parental leave.
Commuting benefits.
Employee Discount Program.
Employee Assistance Program.
Childcare benefits.