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Quality Manager

https://www.baxter.com/ Logo

Baxter

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Location:
Costa Rica , Cartago

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Category:
Manufacturing

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Contract Type:
Not provided

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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:

  • Provide a strong QA presence on the manufacturing floor
  • Support real-time quality decision-making during manufacturing, including line clearances, process adherence, identification of deviations, and resolution of quality issues
  • Act as the primary Quality partner concern point for shop-floor issues that may impact product quality, compliance, or patient safety
  • Own or supervise batch record review, disposition, and product release activities, ensuring documentation is complete, accurate, and compliant prior to release
  • Make independent, risk-based batch release decisions in alignment with quality standards, site procedures, and regulatory expectations
  • Ensure timely batch release while balancing supply continuity and compliance requirements and support interactions with QP or responsible release functions where applicable
  • Lead and handle nonconformances, deviations, and quality events, ensuring issues are accurately detailed, investigated, and closed within defined timelines
  • Drive high-quality root cause analysis and ensure corrective and preventive actions are appropriate, effective, and balanced
  • Ensure CAPAs address systemic issues and actively supervise efficiency to prevent recurrence
  • Lead or offer QA supervision of manufacturing and quality investigations, ensuring investigations are scientifically sound, risk-based, and meet regulatory expectations
  • Review and approve investigation documentation, impact assessments, conclusions, and links to batch disposition and CAPAs
  • Ensure investigation outcomes are clearly supported, traceable, and inspection ready
  • Deliver QA oversight for product complaints, including complaint evaluation, investigation, trending, and regulatory impact assessment as applicable
  • Ensure complaints are assessed regarding their effect on product quality and patient risk, and that documentation meets internal and regulatory requirements
  • Partner with Regulatory Affairs and site team members to support timely complaint responses and reporting obligations where required
  • Support and actively participate in regulatory inspections, internal audits, and customer audits at the site
  • Ensure manufacturing-related quality documentation, including batch records, deviations, investigations, CAPAs, and complaints, is inspection ready
  • Give to responses to audit findings and ensure sustained remediation of identified issues
  • Act as a crucial Quality partner to Manufacturing, Operations, Engineering, Supply Chain, and Site Leadership
  • Provide coaching, mentorship, and training to manufacturing teams on Quality expectations, compliance requirements, and right-first-time behaviors
  • Promote a strong culture of quality ownership, accountability, and continuous improvement while operating in a fast-paced, regulated manufacturing environment
  • Call out quality and compliance risks appropriately to site and Quality leadership

Requirements:

  • Bachelor’s degree experience in science, Engineering, or equivalent
  • 5–8+ years of Quality Assurance experience in regulated manufacturing environments (medical devices, pharmaceuticals, or solutions)
  • Hands-on experience with QA on the floor, batch release, deviations, investigations, CAPA, and complaints
  • Strong understanding of applicable quality systems and legal standards
  • Experience supporting audits and compliance reviews

Nice to have:

  • Experience with FDA QMSR / 21 CFR 820, ISO 13485, 21 CFR 210/211, EU GMP, or combination products
  • Prior site-level Quality leadership experience in manufacturing environments
  • Exposure to continuous improvement or operational quality initiatives
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:
May 16, 2026

Employment Type:
Fulltime
Work Type:
On-site work
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