QA Systems Engineer: Drive Validation & Process Improvement

Baxter International Inc.

Medina (AR)

On-site

USD 76,000 - 105,000

Full time

6 days ago
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Benefits offered by this job

Health and dental coverage from day 1
401(k) Retirement Savings Plan with 2x
Paid holidays and PTO 20–35 days

Job summary

Baxter International Inc. in the United States seeks a Quality Assurance Systems Engineer to join a regulated manufacturing environment. You will validate processes, lead change controls, and prepare technical documentation for audits.

The role emphasizes collaboration with production, quality, and lab teams, applying engineering principles and CAD tools to drive improvements and ensure product quality. Strong communication and multitasking are essential.

Qualifications

  • Bachelor's degree in Engineering; 1-3 years engineering experience preferred.
  • Experience with process improvement methods (e.g. six sigma, lean).
  • Interest in ASQ certifications; manufacturing/medical device experience preferred.
  • Experience in technical communication and cross-functional collaboration.
  • Basic understanding of validation guidelines and cGMPs.
  • Multitasking with strong prioritization; able to meet deadlines.

Responsibilities

  • Support and execute complex validations (IQ, OQ, PQ, MSA) for processes, equipment, test methods and computerized systems.
  • Own and drive change control based on procedures.
  • Assist and communicate with external auditors and project teams.
  • Lead or assist process improvement projects (scrap/defect reduction).
  • Collaborate with production, quality, and laboratory teams.
  • Apply engineering principles and CAD tooling to tasks and scheduling.
  • Prepare data and documentation for technical reviews and projects.
  • Assist management during design, installation, qualification, and monitoring.
  • Provide data-driven analysis after training.
  • Perform other duties as assigned.

Skills

Engineering problem-solving
Cross-functional collaboration
Technical communication
Root cause analysis
Problem solving
Multitasking

Education

Bachelor's degree in Engineering

Tools

CAD software

Job description

Baxter International Inc. in the United States seeks a Quality Assurance Systems Engineer to join a regulated manufacturing environment. You will validate processes, lead change controls, and prepare technical documentation for audits.

The role emphasizes collaboration with production, quality, and lab teams, applying engineering principles and CAD tools to drive improvements and ensure product quality. Strong communication and multitasking are essential.

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