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Sr compliance, QA Engineer

https://www.baxter.com/ Logo

Baxter

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Location:
Costa Rica , Cartago

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Category:
Quality Control

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Contract Type:
Not provided

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Salary:

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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:

  • Own the Complaints, CAPA, Risk Management, Hold and Corrective Actions systems, as well as their critical metrics and participation in local, regional and corporate forums
  • Implement the Internal Audit Program and follow up on corrective and preventive actions
  • Assess the regulatory alignment of processes and systems
  • Ensure they follow applicable directives and standards
  • Coordinate the system for change oversight, making sure changes stay in sync with regulatory requirements
  • Ensure evaluations of complaint samples, manufacturing investigations, and coordination with Product Surveillance within defined timeframes
  • Facilitate root cause analysis and ensure complete documentation in CAPA processes
  • Implement and maintain the risk system, assessing and controlling risks and leading residual risk
  • Ensure the accurate execution of the Hold process and the corrective field actions (FCA)
  • Maintain effective communication with productive areas and lead actions to reduce complaints
  • Plan and implement internal audits, train the audit team, and keep your training program current
  • Coordinate preparation for external audits and ensure timely implementation of corrective or preventive actions
  • Maintain area indicators, communicate deviations, and ensure the plant is up to date with changes in FDA, ISO, or other regulations
  • Review Quality Alerts, 483s and Warning Letters, ensuring the detailed completion of required actions
  • Provide support in GMPs, CAPA and continuous improvement activities and health, safety and environmental programs
  • Ensure ongoing regulatory compliance, leading and communicating changes to FDA, ISO, and other applicable requirements
  • Safeguard compliance during changes to systems or processes and handle the Change Control system
  • Assess regulatory risk through audit information, Quality Alerts, and Field Actions
  • Coordinate gap analysis against international standards and Baxter regulations

Requirements:

  • Minimum of 4 years of experience in manufacturing processes, quality systems, regulatory compliance, and GMPs within Baxter or in companies producing healthcare devices
  • Validated knowledge of ISO 9001, ISO 13485, PMD Law, CMDR, MDSAP, CFR 21 and the Manufacturing Maturity Program (CMMI)
  • Validated experience in auditing systems and certification as an Internal Auditor
  • Knowledge and experience in Sterility Assurance
  • University training in Engineering (Production, Industrial, Chemical, Systems, Electrical, Electronics, Electromechanics) or related career
  • Equivalent experience in production environments with Quality Systems in the medical device manufacturing industry
What we offer:
  • 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:
January 29, 2026

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