QA R&D Principal Engineer

Baxter International

Medolla, Italy

Summary

Covering this position, you’ll have the opportunity to execute Product Quality activities within New Product Development (NPD), Sustaining Engineering (SPO) and Regulatory Compliance projects for dialysis electromechanical devices, 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) and Product Quality Data Review (PQDR) activities.

What you’ll be doing

Be member of Project Core teams for New Product Development Projects and design Change Controls as Product Quality representative;
Executes Product Quality activities within New Product Development (NPD), Sustaining Engineering (SPO) and Regulatory Compliance projects for dialysis electromechanical devices, 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;
Ensures that complaint data and CAPA corrective actions from current products are considered in sustaining engineering activities;
Reviews and approves design NCR/CAPA for the product families assigned;
Retrieves and analyzes Product Quality data in post market phase, in order to trend safety and performance of the devices in the field (PQDR);
Cooperate and support other Company entities for Audits (internal and external) preparation;
Periodically reporting to Product Quality Manager about the status of activities under his/her responsibility.

What you’ll bring

Degree in Engineering (SW, Mechanical or Biomedical field preferred);
3-5 years’ experience in Med-Tech industry with focus on medical devices (R&D experience on electromechanical devices is preferred;
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;
Fluent knowledge of English.

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