Location: Dublin, Ireland
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:
- Essential
- Bachelor’s Degree in Engineering, Science or related field.
- 2 years in a similar role in QA within the medical device industry
- Desirable
- Master’s Degree in Engineering, Science or related field
- Experience with implantable medical devices
- Experience with, or exposure to medical electrical equipment and software
Competencies & Experience:
- Exceptional attention to detail.
- Excellent communicator.
- 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.
- Have strong multi-tasking skills
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.
Ad hoc duties as required.