Onsite QA Validation Engineer for Medical Devices

Baxter International; Town of Ridgeway (NY); Sur place; USD 76 000 - 105 000; Plein temps

Avantages offerts par ce poste

Health insurance

Dental coverage from day one

401(k) with company match

Paid holidays

Paid time off (PTO)

Résumé du poste

Baxter in Medina, NY is seeking a Quality Assurance Systems Engineer to support validated environments, join a cross-functional team, and drive quality improvements on site. The role emphasizes IQ/OQ/PQ/MSA validations, data-driven analysis, and collaboration with production, quality, and laboratory teams.

The ideal candidate holds a Bachelor’s in Engineering with 1–3 years of experience, familiarity with validation guidelines, and a motivation to learn.

Qualifications

• Bachelor's degree in Engineering required with 1–3 years of engineering experience preferred.
• Experience with process improvement methods (e.g., six sigma, lean) is a plus.
• Familiarity with validation guidelines (IQ/OQ/PQ/MSA) and cGMPs is preferred.

Responsabilités

• Support and execute complex validations (IQ/OQ/PQ/MSA) across processes and equipment.
• Own and drive change control based on procedures.
• Assist auditors and participate in audits and projects.
• Lead or participate in process improvement projects to reduce scrap and defects.
• Collaborate with cross-functional teams (production, quality, lab).
• Prepare data and documentation for technical reviews and projects.

Connaissances

Problem solving

Cross-functional work

Technical communication

Multi-tasking

Prioritization

Formation

Bachelor's degree in Engineering

Outils

CAD

Description du poste

Baxter in Medina, NY is seeking a Quality Assurance Systems Engineer to support validated environments, join a cross-functional team, and drive quality improvements on site. The role emphasizes IQ/OQ/PQ/MSA validations, data-driven analysis, and collaboration with production, quality, and laboratory teams.

The ideal candidate holds a Bachelor’s in Engineering with 1–3 years of experience, familiarity with validation guidelines, and a motivation to learn.