Onsite Quality Validation Engineer - IQ/OQ/PQ & Compliance

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

Benefits offered by this job

Health benefits

401(k) with company match

ESPP

Paid time off 20–35 days

Job summary

Baxter is seeking a Quality Assurance Systems Engineer for an on-site role at the Medina, NY site. You will perform validations, support change control, and collaborate with production, quality and lab teams to ensure quality systems are robust and compliant.

The position emphasizes hands-on validation activities, cross-functional communication, and documentation of results, with opportunities for professional development and exposure to cGMP practices.

Qualifications

• Bachelor's degree in Engineering required.
• 1–3 years engineering experience preferred.
• Experience with process improvement methods (Six Sigma, Lean).
• Interest in ASQ certifications is a plus.

Responsibilities

• Support and execute complex validations, including IQ, OQ, PQ, and MSA for processes and equipment.
• Own and drive change control based on procedural requirements.
• Assist or lead audits and validation projects with leadership or participation.
• Lead process improvement projects (scrap/defect reduction) with minimal guidance.
• Collaborate with cross-functional teams (production, quality, laboratory).
• Apply engineering principles and CAD knowledge in project work.
• Prepare technical reviews and organize data and documentation for projects.
• Assist management during design, installation, qualification, or monitoring.
• Provide technical reports and data-driven analyses after training.
• Other duties as assigned.

Skills

Engineering degree

1–3 years experience

Process improvement

ASQ interest

Education

Bachelor's degree in Engineering

Tools

CAD

Job description

Baxter is seeking a Quality Assurance Systems Engineer for an on-site role at the Medina, NY site. You will perform validations, support change control, and collaborate with production, quality and lab teams to ensure quality systems are robust and compliant.

The position emphasizes hands-on validation activities, cross-functional communication, and documentation of results, with opportunities for professional development and exposure to cGMP practices.