QA Systems Engineer: Validation & Quality

Baxter Healthcare; Town of Ridgeway (NY); On-site; USD 76,000 - 105,000; Full time

Benefits offered by this job

Health insurance

Dental coverage

401(k)

Job summary

Baxter Healthcare in Medina, NY is seeking a Quality Assurance Systems Engineer to support complex validations (IQ/OQ/PQ/MSA), drive change controls, and participate in technical reviews with cross-functional teams. You will apply engineering fundamentals to processes and equipment, prepare documentation, assist with design and installation activities, and contribute to data-driven reports.

A bachelor’s in engineering and 1–3 years’ engineering experience are preferred, with opportunities for

Qualifications

• Bachelor’s degree in Engineering; 1–3 years engineering experience preferred.
• Experience with process improvement methods (e.g. six sigma, lean).
• Experience with quality systems in manufacturing/medical device industry.
• Strong technical communication and cross-functional collaboration.
• Understanding of validation guidelines (cGMP) preferred.
• Multitasking with good prioritization.
• Willingness to support development and deployment of new processes/technologies.

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 other validations or projects.
• Assist or lead process improvement projects with little guidance.
• Work with cross-functional teams (production, quality, lab, etc.).
• Apply engineering principles and CAD scheduling and planning of technical tasks.
• Assist in preparation and participation of technical reviews and documentation.
• Assist management or other engineers during process design, equipment installation, qualification.
• Provide technical reports and data-driven analyses after training.
• Other duties as assigned.

Skills

Validation

Auditing

Documentation

Cross-functional

Problem solving

Education

Bachelor's degree in Engineering

Tools

CAD

MS Office

Job description

Baxter Healthcare in Medina, NY is seeking a Quality Assurance Systems Engineer to support complex validations (IQ/OQ/PQ/MSA), drive change controls, and participate in technical reviews with cross-functional teams. You will apply engineering fundamentals to processes and equipment, prepare documentation, assist with design and installation activities, and contribute to data-driven reports.

A bachelor’s in engineering and 1–3 years’ engineering experience are preferred, with opportunities for