Quality Assurance Systems Engineer - Validation & Process

Socket.dev; Town of Ridgeway (NY); On-site; USD 76,000 - 105,000; Full time

Benefits offered by this job

Medical and dental coverage

401(k) with company match

Employee stock purchase plan (ESPP)

Paid time off 20–35 days

Job summary

Baxter is seeking a Quality Assurance Systems Engineer to join our team and support validations, change control, and cross-functional projects. You will collaborate with production, quality, and laboratory teams while applying solid engineering principles and documentation practices.

The role requires a Bachelor's in Engineering with 1–3 years of engineering experience, knowledge of cGMPs, and comfort with audits. Competitive base salary and comprehensive benefits are offered.

Qualifications

• Bachelor's degree in Engineering.
• 1-3 years of engineering experience preferred.
• Experience with process improvement methods (six sigma, lean).
• ASQ certifications and medical device industry exposure are a plus.
• Experience with technical communication and cross-functional collaboration.

Responsibilities

• Support and execute complex validations (IQ/OQ/PQ/MSA) for processes, equipment, and software systems.
• Own and drive change control based on procedural requirements.
• Assist external auditors and lead or participate in validations.
• Lead or assist process improvement projects with minimal guidance.
• Collaborate with production, quality, and laboratory teams.
• Apply engineering principles and CAD in design and scheduling tasks.
• Prepare technical reviews and documentation for projects.
• Assist with equipment installation, qualification, and monitoring.
• Provide data-driven analysis and technical reports after training.
• Perform other duties as assigned.

Skills

Engineering degree

Process improvement

Quality systems

Cross-functional collab

Auditing experience

Education

Bachelor's degree in Engineering

Tools

CAD

Job description

Baxter is seeking a Quality Assurance Systems Engineer to join our team and support validations, change control, and cross-functional projects. You will collaborate with production, quality, and laboratory teams while applying solid engineering principles and documentation practices.

The role requires a Bachelor's in Engineering with 1–3 years of engineering experience, knowledge of cGMPs, and comfort with audits. Competitive base salary and comprehensive benefits are offered.