Quality Systems Engineer: Validation & Process Improvement

Zvh; Kentucky; On-site; USD 76,000 - 105,000; Full time

Benefits offered by this job

Medical and dental coverage start day

401(k) Retirement Savings Plan

Employee Stock Purchase Plan (ESPP)

Paid holidays and paid time off 20–35

Bonus eligibility

Job summary

Baxter is seeking a Quality Assurance Systems Engineer to support complex validations and drive change control within a regulated manufacturing environment. You will collaborate with production, quality, and lab teams to ensure quality systems are robust and compliant.

Ideal candidates have 1-3 years of engineering experience, a Bachelor's in Engineering, and an interest in Six Sigma/Lean, with ASQ certification pursued. This on-site role offers comprehensive benefits and growth opportunities.

Qualifications

• Bachelor's degree in Engineering.
• 1-3 years of engineering experience preferred.
• Experience with process improvement methods (e.g. Six Sigma, Lean).
• Interest in obtaining certifications (ASQ).
• Experience in manufacturing/medical device industry; development and deployment of Quality Systems preferred.

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 procedural requirements.
• Assist or lead audits and validation projects with leadership involvement.
• Assist or lead process improvement projects with minimal guidance.
• Collaborate with cross-functional teams (production, quality, lab).
• Apply engineering principles and CAD-related scheduling to tasks.
• Prepare data and documentation for technical reviews and projects.
• Support design, installation, qualification, and monitoring of processes and equipment.

Skills

Engineering experience

Process improvement

ASQ certification

Technical communication

Cross-functional collaboration

Root cause analysis

Quality systems

Education

Bachelor's degree in Engineering

Job description

Baxter is seeking a Quality Assurance Systems Engineer to support complex validations and drive change control within a regulated manufacturing environment. You will collaborate with production, quality, and lab teams to ensure quality systems are robust and compliant.

Ideal candidates have 1-3 years of engineering experience, a Bachelor's in Engineering, and an interest in Six Sigma/Lean, with ASQ certification pursued. This on-site role offers comprehensive benefits and growth opportunities.