Quality Engineer

About the role

The Quality Engineer will ensure compliance with Quality System Regulations for manufacturing processes at Baxter's Aibonito facility. The role provides technical statistical support, process control, and guidance to maintain internal and external regulatory standards.

Key responsibilities

• Ensure compliance with GMP, FDA, ISO and other regulatory requirements.
• Lead root‑cause investigations and drive corrective and preventive actions.
• Support process validation, equipment and software validation, and continuous process verification programs.
• Develop and evaluate quality sampling plans and statistical techniques.
• Review and approve documentation, non‑conformance investigations, and sterilization alarms.
• Prepare monthly and quarterly quality data reviews and reports for management.
• Participate in internal and external audits and maintain quality program records.

Required profile

• Bachelor’s degree in Engineering.
• At least one year of experience in quality engineering or statistical applications.
• Fully bilingual in English and Spanish.
• Willingness to travel occasionally.

Required skills

• Statistical analysis and data review.
• Proficiency with Microsoft Office, Outlook, Trackwise and TcU.
• Knowledge of GMP, FDA regulations and ISO standards.
• Process validation and software validation expertise.
• Root‑cause investigation and corrective‑action methodology.
• Experience with Continuous Process Verification (CPV) programs.

What we offer

• Medical, dental and vision coverage starting day one.
• Life, accident, short‑term and long‑term disability insurance.
• Employee Stock Purchase Plan and 401(k) with company match.
• Flexible Spending Accounts, educational assistance and paid parental leave.
• Paid time off ranging from 20 to 35 days, plus holidays and leave of absence.