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Quality Assurance Specialist

3 weeks ago

Limerick, Limerick, Ireland BD Medical Full time

At BD Medical, we are committed to advancing the world of health. We believe that quality is not just a requirement, but a fundamental aspect of our culture. As a Quality Assurance Specialist, you will play a critical role in ensuring that our design changes meet the highest standards of quality and compliance.

About the Role

The Change Control Coordinator is responsible for leading the change process from concept to execution. This involves creating and maintaining change records, overseeing all phases of the change process, and assessing potential impacts while implementing mitigation strategies.

Main Responsibilities:
  • Support and Drive Design Changes: Lead the change process from concept to execution.
  • Change Records Management: Create and maintain change records in the change management system.
  • Oversee Change Phases: Ensure all phases of the change process are completed with high quality and within the designated timelines.
  • Impact Assessment and Mitigation: Identify residual impacts following a change and propose mitigation activities.
Requirements:
  • Educational Background: A relevant degree (engineering degree preferred) or a minimum of 3 years of quality engineering/system experience.
  • Regulatory Knowledge: Familiarity with ISO 13485, QSR and MDR.

We welcome people with strong written and verbal communication abilities who can see the bigger picture and understand the human story that underpins everything we do. If you have a passion for quality and a drive to make a difference, we encourage you to apply.