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Search Results for QA RA Engineer
QA SpecialistOur client in Cork, a leading pharma company, are seeking an experienced QA specialist. This individual will contribute to the implementation and maintenance of Quality Assurance actions in compliance with the current GMP regulations. With primary responsibility for the quality assurance in Operations and Manufacturing and the relevant supporting departments such as Laboratory, Validation, Engineering and Warehouse. Responsibilities: Product release activities Review all documentation associated with batch release to ensure GMP compliance. Ensure the follow-up of the nec...
Other Medical Device Jobs
QA RA Engineer Career Profile
QA / RA SpecialistA role combining Quality Assurance and Regulatory Affairs, more often found in the Medical Device sector
- 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