Quality Engineer — GMP & Process Compliance

Baxter Healthcare; Aibonito (PR); On-site; USD 65,000 - 90,000; Full time

Job summary

Baxter in Aibonito, Puerto Rico, seeks a qualified quality professional to ensure GMP, FDA, and ISO compliance and to provide technical support for process control. The role includes leading investigations, supporting change control, and ensuring regulatory readiness across the facility.

You will collaborate with cross-functional teams to drive continuous improvement, review documentation, and maintain quality programs in a fast-paced manufacturing environment. Bilingual English/Spanish required.

Qualifications

• Bachelor's degree in engineering required.
• Statistical applications knowledge needed.
• Fully bilingual (English & Spanish).

Responsibilities

• Ensure compliance with GMP, FDA, ISO requirements.
• Provide technical support for process control at the Aibonito facility.
• Lead/participate in root cause investigations and quality projects.

Skills

Statistical applications

Bilingual English/Spanish

Regulatory compliance

Quality systems

Education

Bachelor's degree in engineering

Tools

Microsoft Office

TrackWise

TcU

Job description

Baxter in Aibonito, Puerto Rico, seeks a qualified quality professional to ensure GMP, FDA, and ISO compliance and to provide technical support for process control. The role includes leading investigations, supporting change control, and ensuring regulatory readiness across the facility.

You will collaborate with cross-functional teams to drive continuous improvement, review documentation, and maintain quality programs in a fast-paced manufacturing environment. Bilingual English/Spanish required.