Onsite QA Systems Engineer: Validation & Process

Baxter International Inc.; Town of Ridgeway (NY); On-site; USD 90,000 - 120,000; Full time

Benefits offered by this job

Medical and dental coverage starting 1

401(k) with company match

Employee Stock Purchase Plan (ESPP)

Paid time off 20–35 days

Job summary

Baxter International Inc. is seeking a Quality Assurance Systems Engineer for an onsite role in Medina, NY.

The position emphasizes complex validations, change control, and collaboration with cross-functional teams to ensure regulatory compliance and product quality. A bachelor’s degree in engineering and 1–3 years of experience are preferred, with opportunity to grow in a FDA-regulated manufacturing environment.

Qualifications

• Bachelor's degree in Engineering; 1–3 years engineering experience preferred.
• Prefers experience with process improvement methods (e.g. six sigma, lean).
• Experience with manufacturing/medical device industry and quality systems development.

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, present, defend, and communicate with external auditors and projects.
• Lead or participate in process improvement projects with minimal guidance.
• Work with cross-functional teams (production, quality, laboratory).
• Apply engineering principles and CAD knowledge to tasks and documentation.

Skills

Engineering degree

Validation experience

Cross-functional collaboration

Communication

Six Sigma / Lean

Problem solving

Education

Bachelor's degree in Engineering

Tools

CAD

Job description

Baxter International Inc. is seeking a Quality Assurance Systems Engineer for an onsite role in Medina, NY.

The position emphasizes complex validations, change control, and collaboration with cross-functional teams to ensure regulatory compliance and product quality. A bachelor’s degree in engineering and 1–3 years of experience are preferred, with opportunity to grow in a FDA-regulated manufacturing environment.