Quality Assurance Engineer

4 settimane fa

Medolla, Emilia-Romagna, Italia Baxter A tempo pieno

Visionary Quality Leadership

Baxter is embarking on a transformative journey to separate our ~$5B Kidney Care segment into a standalone company, Vantive. This bold move will build on our nearly 70-year legacy in acute therapies and home and in-center dialysis, providing best-in-class care to those we serve. We believe Vantive will not only solidify our leadership in the kidney care space but also offer meaningful work to those who join us.

About Vantive

At Vantive, you will become part of a community of driven individuals focused on improving patients' lives worldwide. We are revolutionizing kidney care and other vital organ support, and we invite you to be a part of this groundbreaking effort.

Your Role

Covering this position, you'll have the opportunity to implement Product Quality activities within New Product Development (NPD), Sustaining Engineering (SPO), and Regulatory Compliance projects for chronic and acute blood sets disposables, based on the project assignments received by the Product Quality Manager.

You'll also participate directly in projects for continuous improvement of product quality handling design NCR/CAPA (as quality approver).

Key Responsibilities

  • Be a member of Project Core teams for New Product Development Projects and design Change Controls as Product Quality representative.
  • Perform Product Quality activities within New Product Development (NPD), Sustaining Engineering (SPO), and Regulatory Compliance projects for chronic and acute blood sets disposables, based on the project assignments received by the Product Quality Manager.
  • Review the documents for Device History File issuing and maintenance.
  • Assure compliance to all applicable Baxter corporate procedures as well as all local work instructions and applicable laws and standards.
  • Ensure that complaint data and CAPA corrective actions from current products are considered in sustaining engineering activities.
  • Quality approver of design NCR/CAPA for the product families assigned.
  • Collaborate and support other Company entities for Audits (internal and external) preparation.
  • Periodically report to Product Quality Manager about the status of activities under his/her responsibility.

Requirements

We're looking for a highly skilled individual with:

  • 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
  • Knowledge of Design Control and Risk Management principles
  • Critical thinking, problem-solving, collaboration, communications, and negotiation skills are required
  • Proficient knowledge of English

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