Quality Engineer - GMP Compliance & Process Improvement

Baxter International Inc.; Aibonito (PR); On-site; USD 70,000 - 95,000; Full time

Benefits offered by this job

Medical and dental coverage on day one

401(k) with company match

Employee Stock Purchase Plan

Paid time off 20–35 days

Job summary

Baxter International Inc. in Aibonito, Puerto Rico, seeks a quality professional to ensure compliance with Quality System Regulation across processes and methods. You will provide technical support to ensure process control and participate in validations, audits, and CAPA activities.

The role requires engineering education, willingness to travel, and strong English/Spanish communication skills. You will contribute to continuous improvement and work under GMP/ GDP guidelines to protect patient

Qualifications

• Bachelor’s degree in engineering with at least 1 year of experience and knowledge of statistical applications.
• Familiarity with GMP, FDA, ISO, and quality systems.
• Ability to communicate effectively at all plant levels and to travel occasionally.

Responsibilities

• Ensure compliance with Quality System Regulation for processes and methods.
• Provide technical support to Aibonito facility to assure process control.
• Lead root cause investigations and CAPA activities.
• Participate in process validation and software/database validation.
• Review documentation for GMP/GDP compliance and assist in quality data reviews.
• Coordinate cross-functional meetings and drive continuous improvement initiatives.

Skills

Engineering knowledge

Statistical methods

Communication skills

Leadership potential

Bilingual English/Spanish

Travel flexibility

Education

Bachelor’s degree in engineering

Tools

Microsoft Office

Outlook

Trackwise

TcU

Job description

Baxter International Inc. in Aibonito, Puerto Rico, seeks a quality professional to ensure compliance with Quality System Regulation across processes and methods. You will provide technical support to ensure process control and participate in validations, audits, and CAPA activities.

The role requires engineering education, willingness to travel, and strong English/Spanish communication skills. You will contribute to continuous improvement and work under GMP/ GDP guidelines to protect patient