Sr Quality Systems Engineer

Baxter

Not specified
4 years manufacturing quality systems experience
Iso 13485 and fda cfr 21 knowledge
Internal auditor certification required
Baxter is seeking a Senior Quality Systems Engineer to enhance its compliance and quality assurance processes within its manufacturing operations. The role emphasizes regulatory compliance, internal audits, and risk management, requiring significant experience in quality systems, particularly within the healthcare device industry

Job Summary

  • This role combines responsibilities in CAPA, Complaints, Risk, Internal Audit, and Regulatory Affairs to ensure conformity with regulatory mandates.
  • The position requires owning the Complaint, CAPA, Risk Management, Hold, and Corrective Actions systems while driving efficiency at the Baxter Cartago plant.
  • Candidates must possess validated knowledge of ISO 9001, ISO 13485, and FDA regulations along with a university degree in Engineering.

Matching Summary

Match Score: 85

Baxter is seeking a Senior Quality Systems Engineer to enhance its compliance and quality assurance processes within its manufacturing operations. The role emphasizes regulatory compliance, internal audits, and risk management, requiring significant experience in quality systems, particularly within the healthcare device industry.

Skills & Requirements

Must-have

  • 4 years manufacturing quality systems experience
  • ISO 13485 and FDA CFR 21 knowledge
  • Internal auditor certification required
  • CAPA and complaint management expertise
  • Sterility assurance knowledge

Nice-to-have

  • MDSAP and PMD Law familiarity
  • CMMI Manufacturing Maturity Program
  • Change control system coordination
  • Cross-functional team collaboration
  • Continuous improvement mindset

Key Requirements

  • Minimum 4 years experience in healthcare device manufacturing
  • Validated internal auditor certification
  • University training in Engineering or related career
  • Knowledge of Sterility Assurance processes
  • Experience with GMPs and regulatory compliance

Work Rights

Not specified

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