Quality Engineer I — Process & Compliance Innovator

Baxter Healthcare; Aibonito (PR); On-site; USD 65,000 - 85,000; Full time

Benefits offered by this job

Medical and dental coverage from day 1

401(k) with company match

Employee Stock Purchase Plan (ESPP)

Paid holidays and PTO

Parental leave

Job summary

Baxter Healthcare seeks an Engineer I in Quality to insure compliance with quality systems at the Aibonito facility. You will support process control, participate in audits and drive CAPA activities. Strong engineering background and bilingual English/Spanish are required, with collaboration across diverse teams.

Responsibilities include root-cause investigations, data analysis, and documentation reviews in a fast-paced hospital products environment. This role reports to the QA Manager.

Qualifications

• Engineering degree with knowledge of quality systems and regulatory practices.
• Experience applying GMP, FDA, ISO requirements in a manufacturing setting.
• Ability to perform root cause investigations and CAPA activities.

Responsibilities

• Lead investigations for quality issues and drive corrective actions.
• Ensure compliance with GMP, FDA, ISO requirements and internal standards.
• Provide technical support to maintain process control at the Aibonito facility.
• Participate in internal and external audits and data reviews.
• Review documentation and SOPs to ensure accuracy and compliance.
• Collaborate with cross-functional teams to implement improvements.

Skills

Quality assurance

Root cause analysis

Statistical methods

Regulatory compliance

Cross-functional teamwork

Documentation

Communication

Education

Bachelors Degree in Engineering

Tools

TrackWise

Microsoft Office

Outlook

TcU

Job description

Baxter Healthcare seeks an Engineer I in Quality to insure compliance with quality systems at the Aibonito facility. You will support process control, participate in audits and drive CAPA activities. Strong engineering background and bilingual English/Spanish are required, with collaboration across diverse teams.

Responsibilities include root-cause investigations, data analysis, and documentation reviews in a fast-paced hospital products environment. This role reports to the QA Manager.