Quality Engineer I

Key Responsibilities

• Perform process validation, process capability, and process control studies for assigned areas.
• Drive quality/manufacturing projects by applying Lean, problem-solving, process control, and project management tools to achieve and sustain operational excellence.
• Support Manufacturing, Engineering, and Quality Management departments with the development and implementation of new processes and technology.
• Assist in identifying and developing process improvement projects, including automation and computerization.
• Ensure computer systems and applications align with regulatory quality standards through validation activities.
• Ensure FDA regulations are met for system upgrades and replacements.
• Ensure the quality of facility systems by writing and completing protocols and test cases for validations. Coordinate testing and detailing of projects.
• Perform and deliver changes to applications and assist in training for systems.
• Apply diversified knowledge of applied Statistical Analysis techniques, procedures, and criteria to carry out measurements, process, and product capability studies toward the development of new or refined equipment, materials, processes, instruments, and products.
• Communicate effectively in written and verbal form and function effectively as a team member.
• Align with plant and department environmental health and safety regulations.
• Learn, understand, and apply rigorous quality standards, established guidelines, and current Good Manufacturing Practices (cGMP).
• Notify the supervisor and take appropriate action if any safety, quality, mechanical, or discrepancy issues occur.
• Sustain a clean and safe work area using 6S principles.
• Perform all other duties and responsibilities as determined by supervision/management.

Requirements & Tech Stack

• Knowledge of applications such as Wonderware, Allen-Bradley PLC, Access, and Microsoft Project preferred.
• ASQ Certification (CQE or CSQE) or equivalent desired.
• Strong leadership skills and the ability to work with diversified 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 desired.
• Meet visual acuity requirements as detailed in the Baxter Cleveland Visual Acuity Procedure CL-01-01-037.

Physical Requirements

• 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/stoop.

Education And Experience

• BS degree in Engineering, Computer Science, or other core Science Field and 0-1 year related experience (in-house, co-op, or acquired outside).