Quality Engineer, Baxter

Baxter

Location:

United States of America, Aibonito

Category:

Quality Control

Contract Type:

Employment contract

Salary:

Not provided

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Job Description:

As a Quality Engineer at Baxter, your role will involve leading various aspects of Quality System Regulation compliance, providing technical expertise, and supporting the Aibonito facility. This includes ensuring compliance with GMP, FDA, and ISO standards, evaluating customer complaints, supporting sterilization processes, and engaging in continuous improvement initiatives.

Job Responsibility:

Ensure compliance and provide Quality mentorship for process/area responsibilities
identify and assess regulatory and quality risks in activities and processes according to regulatory agency rules, guidelines, and Baxter quality practices
lead and conduct root cause investigations for multi-group projects, encouraging continuous improvement and corrective/preventative action strategies
support the Aibonito facility with technical knowledge, modification specifications, procedures, special tests, and/or projects
maintain full knowledge of the Quality Operations
participate in the process validation and protocols of equipment and/or subassemblies
participate in the Software Validations and Protocols of equipment and/or database applications
engage in Quality Programs and ensure compliance with GMP, FDA, ISO, and other Regulatory Agencies
review documentation for compliance with GMP and GDP
support the design, development, and improvement of product processes and technology modifications
evaluate customer complaints and conduct Non-conformance Investigations, providing approvals as a quality representative
develop and evaluate Quality Sampling Plans and techniques for further improvement
coordinate the Continuous Process Verification (CPV) program and any special projects assigned
observe all company and regulatory EHS requirements
prepare monthly and quarterly Quality Data Reviews
participate in internal and external audits
analyze Defects per Million (DPM) per defect/product monthly, considering equivalent experience
lead assigned programs (e.g., Sterilization, Parametric Release) from a quality standpoint to ensure compliance, reviewing and approving related documentation
evaluate sterilization alarms and provide final product disposition based on procedures and specifications
provide feedback and support to steam sterilization projects as a subject matter expert
perform any necessary work to avoid delays in product release
apply Computer Programs (e.g., Microsoft Office, Outlook, Trackwise, TcU)
coordinate and participate in meetings with multidisciplinary teams as required
prepare reports for management review and quality data indicators
work effectively within a team-oriented environment
manage multiple tasks simultaneously with minimal supervision
align with established project objectives and timelines
communicate effectively at all plant levels.

Requirements:

Bachelor’s Degree in Engineering
at least one-year experience with statistical applications knowledge
proficiency in engineering and management practices, statistical methods, computer systems, and technical reporting
a self-starter with an in-depth understanding of Quality day-to-day activities
effective communication skills across all levels of personnel
ability to supervise efficiently and in a timely manner
willingness to travel occasionally
fully bilingual (English & Spanish).

What we offer:

Vacation and Paid Holidays
medical, dental, disability and life insurance coverage
vision and voluntary benefits
paid parental leave
retirement savings plan – 165E
employee stock purchase program
educational assistance plan
paid time off
employee health and well-being benefits.

Additional Information:

Job Posted:

March 20, 2025

Employment Type:

Fulltime

Work Type:

On-site work

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Quality Engineer