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Tech, QA Assurance

https://www.baxter.com/ Logo

Baxter

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Location:
Puerto Rico , Aibonito

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Category:
Quality Control

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Contract Type:
Employment contract

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Salary:

Not provided
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Job Description:

This is where you make a difference in our patients' safety. As a member of the Baxter Quality team, you will play an essential part in our mission of saving and sustaining lives. Quality is important throughout the entire product lifecycle and works collaboratively with all areas of the organization. Because Quality touches everything Baxter does, a role in Quality provides many opportunities for growth, learning and a successful career that has a daily impact on people's lives.

Job Responsibility:

  • Ensure compliance with Quality System Regulations related to manufacturing processes, methods, and quality functions
  • Review and approve quality documentation, including In-Process Checker Charts, Product Retention Records, Control Charts, Mold Approvals, Batch Records, and related records
  • Conduct routine manufacturing audits of machine parameters, setups, and finished product to ensure compliance with specifications and procedures
  • Audit sampling techniques, testing skills, and documentation executed by TIQs
  • Provide immediate notification and escalation to Quality Management regarding potential quality issues or risks
  • Assist and coordinate quality and manufacturing protocols, including validation and improvement initiatives
  • Provide training on Good Documentation Practices (GDP), Statistical Process Control (SPC), Total Integrated Quality, and related quality tools
  • Support mold approval activities and mold startup evaluations, when applicable
  • Gather, analyze, audit, and interpret data using SPC tools to identify trends and recommend process improvements that reduce scrap, DPMs, complaints, and cost of non-conformance
  • Maintain, review, audit, and calculate control chart limits as required
  • Ensure all machinery, equipment, tools, and measuring devices comply with Corporate, GMP, and regulatory requirements
  • Publish monthly Quality Indicators, including DPMs and Pareto analyses for assigned areas
  • Propose and submit improvements or modifications to specifications and Standard Operating Procedures
  • Maintain timely communication with internal and external customers/suppliers regarding quality trends, complaints, and DPM performance, as applicable
  • Assist in the development and certification of TIQs
  • Participate in and lead special projects related to assigned quality responsibility areas
  • Manually and electronically document required process and production information (e.g., checker charts, POMs) per procedures and specifications
  • Conduct EHS inspections to identify safety hazards and environmental aspects
  • analyze incidents and near misses and implement corrective actions
  • Support software application audit execution
  • Assist in the generation, investigation, and resolution of non-conformances
  • Observe data privacy and confidentiality policies at all times

Requirements:

  • Bachelor's Degree in Science or related field
  • Minimum of two (2) years of Quality experience within the Medical Device industry
  • Experience using measurement and inspection instrumentation
  • Strong analytical, auditing, and documentation skills
  • Effective interpersonal and communication skills
  • Bilingual (English & Spanish)
What we offer:
  • Medical, Dental, Disability, and Life Insurance Coverage
  • Vision Plan
  • Paid Vacation Days and Paid Holidays
  • Paid Parental Leave
  • Retirement Plan
  • Employee Stock Purchase Program
  • Educational Assistance Plan
  • Support for Parents
  • Continuing Education/ Professional Development
  • Employee Heath & Well-Being Benefits
  • Paid Time Off
  • 2 Days a Year to Volunteer

Additional Information:

Job Posted:
May 14, 2026

Employment Type:
Fulltime
Work Type:
On-site work
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