Product Development Engineer
2 weeks ago
We are seeking a Quality Assurance Specialist to join our team in a permanent role. This is an exciting opportunity for a skilled professional to contribute to the advancement of medical science and improve patient lives.
The successful candidate will play a key role in demonstrating commitment to quality practices and maintaining an effective quality system. They will support the application of design controls in projects, including the development of new medical devices.
Key Responsibilities- Ensure compliance with regulatory requirements and procedures that govern medical device design control.
- Develop and maintain Design History Files, supporting deliverables such as design inputs, design outputs, design verification, and design validation.
- Provide quality assurance support in the resolution of PIRs, CAPAs, NCEPs, and regulatory requirement changes.
- Interface with R&D, Regulatory Affairs, Clinical Risk, Medical Safety, and Operations teams to provide technical and quality systems input.
- NFQ Level 8 qualification in a STEM discipline
- Minimum 3 years industry experience; Design Assurance experience would be an advantage
- Strong technical capabilities, communication and collaboration skills, and ability to adapt and flex across projects
Opportunity to work on cutting-edge medical devices
Collaborative and dynamic work environment
Professional development and growth opportunities
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