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| Job Title | Location | Salary | |
| Quality Engineer | Dublin | Not Disclosed |
|
| Senior Regulatory Affairs Specialist | Dublin | Not Disclosed |
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QA RA Engineer Career Profile
QA / RA Specialist
A role combining Quality Assurance and Regulatory Affairs, more often found in the Medical Device sectorMain Responsibilities
- Apply technical solutions to problem solving
- Apply technical solutions to quality improvement projects
- Use technical writing skills to clearly describe technical information Analyze customer complaints, identify trends and execute corrective actions
- Understand standards and their application to medical devices
- Planning, protocol generation, testing and report generation for medical devices
- Generation and maintenance of technical files for medical devices
- Review and update technical files in line with EU medical devices regulatory requirements
- The use of harmonised standards when compiling a technical file in compliance with the MDD
- Ensuring that records are filed in accordance with site procedures
- Supporting R&D
Skills / Experience
- Engineering / Science qualification
- 3/4 years experience within R&D / QA/ RA/ Compliance or Validation function in a Medical Device Environment
- Excellent technical writing experience within a medical device environment
- 2/3 years experience in Risk, Clinical and Biocompatibility an advantage
- Fluency in English