Sr Quality Systems Engineer

Baxter

**
4+ years manufacturing quality systems experience
Validated knowledge of iso 13485 and fda regulations
Experience with capa, complaints, and risk management
** Baxter is seeking a Sr Quality Systems Engineer to oversee compliance with quality systems, regulatory affairs, and internal audits at their Cartago plant. The ideal candidate should have a strong background in quality systems within the medical device manufacturing industry and a solid understanding of relevant regulatory standards. **

Job Summary

  • This role combines responsibilities in CAPA, Complaints, Risk, Internal Audit, and Regulatory Affairs to ensure conformity with regulatory mandates.
  • The candidate will lead the implementation of internal audits, coordinate external audit preparations, and maintain area indicators for plant compliance.
  • Baxter is a global healthcare company united by a mission to save and sustain lives, offering a culture of courage, trust, and collaboration.

Matching Summary

Match Score: 75

** Baxter is seeking a Sr Quality Systems Engineer to oversee compliance with quality systems, regulatory affairs, and internal audits at their Cartago plant. The ideal candidate should have a strong background in quality systems within the medical device manufacturing industry and a solid understanding of relevant regulatory standards. **

Skills & Requirements

Must-have

  • 4+ years manufacturing quality systems experience
  • Validated knowledge of ISO 13485 and FDA regulations
  • Experience with CAPA, Complaints, and Risk Management
  • Internal Auditor certification required
  • Knowledge of Sterility Assurance processes

Nice-to-have

  • MDSAP and CMMI framework familiarity
  • Strong communication in corporate forums
  • Continuous improvement mindset
  • Collaborative team culture participation

Key Requirements

  • Minimum 4 years experience in medical device manufacturing
  • University degree in Engineering or related field
  • Certification as an Internal Auditor
  • Validated knowledge of PMD Law and CMDR

Work Rights

Not specified

Tailored Resume

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