Quality Engineer I: GMP/ISO Compliance & Process Improvement

Zvh; Aibonito (PR); On-site; USD 60,000 - 85,000; Full time

Benefits offered by this job

Health insurance

Retirement plan (401k)

Job summary

Baxter in Puerto Rico seeks an Engineer I in Quality to ensure compliance with quality systems and manufacturing processes. The incumbent will provide technical support to ensure process control and participate in audits and improvements.

The role requires knowledge of GMP/ISO, experience with statistical methods, and the ability to work with cross-functional teams. English and Spanish fluency is required.

Qualifications

• Bachelor's Degree in Engineering and at least one year of experience with statistical applications.
• Uses engineering and management practices, statistical methods and technical reporting.
• Fully bilingual (English & Spanish).

Responsibilities

• Ensure compliance with GMP, FDA, ISO and other regulatory requirements.
• Lead root cause investigations for cross-functional projects.
• Provide technical support and knowledge to maintain process control.
• Participate in validations, software validations, and quality programs.
• Prepare monthly and quarterly quality data reviews.

Skills

Quality engineering

Statistical methods

Project coordination

Communication

Microsoft Office

Trackwise

Outlook

TcU

Education

Bachelors Degree in Engineering

Tools

Trackwise

Outlook

Microsoft Office

TcU

Job description

Baxter in Puerto Rico seeks an Engineer I in Quality to ensure compliance with quality systems and manufacturing processes. The incumbent will provide technical support to ensure process control and participate in audits and improvements.

The role requires knowledge of GMP/ISO, experience with statistical methods, and the ability to work with cross-functional teams. English and Spanish fluency is required.