Quality Assurance Engineer

3 settimane fa


Medolla, Emilia-Romagna, Italia Baxter A tempo pieno

Visionary Quality Leadership

Baxter is revolutionizing kidney care and other vital organ support. As a Quality Assurance Engineer, you will play a critical role in ensuring the highest quality standards are met in our products and services.

Key Responsibilities

  • Implement Product Quality activities within New Product Development (NPD), Sustaining Engineering (SPO), and Regulatory Compliance projects for chronic and acute blood sets disposables.
  • Participate in projects for continuous improvement of product quality handling design NCR/CAPA as quality approver.
  • Review documents for Device History File issuing and maintenance.
  • Ensure compliance to all applicable Baxter corporate procedures, local work instructions, and applicable laws and standards.
  • Collaborate with other Company entities for Audits (internal and external) preparation.

Requirements

  • Degree in Engineering in the Biomedical field or Life sciences (Chemistry, biology...).
  • Previous experience in the Med-Tech industry with focus on medical devices.
  • Knowledge and experience of Quality System based on ISO 13485, FDA, CFR, GMP regulation, and MDSAP.
  • Critical thinking, problem-solving, collaboration, communications, and negotiation skills are required.
  • Proficient knowledge of English.


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