QA Engineer

4 weeks ago


Dublin, Dublin City, Ireland FIRE1 Foundry Full time

Reports to: VP of Quality and Regulatory Affairs

Role Purpose:

To support the execution of FIRE1's quality management system and represent the quality function cross-functionally including quality support on process development and manufacturing/supply chain projects

Knowledge & Education:
  • Bachelor's Degree in Engineering, Science or related field.
  • 2 years in a similar role in QA within the medical device industry
  • Master's Degree in Engineering, Science or related field
  • Experience with implantable medical devices
  • Experience with, or exposure to medical electrical equipment and software
  • Exceptional attention to detail.
  • Well organised with ability to work to deadlines.
  • An aptitude for identifying & implementing process improvements.
  • Ability to proactively identify issues and make recommendations.
  • Proven ability to function efficiently in a faced-paced environment with multiple and shifting priorities.
Responsibilities/Key Objectives:

Quality support with process development and change control across equipment design, process parameters, component control and inspections

Use of statistical methods and tools to trend quality metrics and key performance indicators within the FIRE1 Quality Management System (QMS)

Handling of quality events including non-conformances and root cause analysis within FIRE1 QMS

Preparation and management of all aspects of document control within the FIRE1 QMS according to the requirements of ISO13485.

Development of quality procedures and work instructions in support of the FIRE1 QMS

Support with Internal and External Audits

Engagement with various stakeholders as required including suppliers and regulatory authorities.

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