Our Client a major multinational based here in Galway are looking for a Quality Engineer for an exciting new project on a fixed-term contract.
The Quality Engineer provides a support role to the Quality Manager in the routine maintenance of the Quality Management Systems and in Quality related projects.
The Quality Engineer reports to the Senior Quality Engineer.
- Identifies problems and possible solutions and takes appropriate action to resolve them. Demonstrates skill in data analysis techniques.
- Applies problem-solving skills in order to deal creatively with complex situations, work that typically requires processing and interpreting, more complex, less clearly-defined issues.
- Seeks consensus for decisions under conditions of uncertainty, sometimes with incomplete information, in order to produce effective end results. Applies risk assessment techniques in such circumstances.
- Investigation & appropriately documenting non-conformance & CAPA
- Possesses and applies a broad and increasing knowledge of Quality to the completion of moderately complex assignments.
- Drives business improvements through continuous improvement initiatives.
- Escalation point for quality-related non-conformances and CAPAs.
- Drives compliance cross-functionally in alignment with the regional objective for collaboration and multi-site ISO13485 certification.
- Drives compliance across departments and Business Units through communication and collaboration to ensure that Quality System requirements are met throughout
- Supports assigned project teams by providing analysis and expertise throughout the project planning and implementation phases
- Participate in internal and external audit
- Third-level qualification.
- Minimum 3 years of experience in the medical device industry with progressively responsible positions including; Competent working knowledge of recognized Quality Management Systems (e.g. ISO9001/ ISO13485/ ISO14971/ GMP),
- Awareness of relevant laws and regulations (e.g. MDR / IVDR / FDA)
- Broad knowledge of engineering and technical applications applied in the development of medical devices & IVD’s useful.
- Experience in supply chain / distribution / warehouse management / facility validation desirable
- Excellent interpersonal, written, and verbal communication skills, including the ability to make clear, well-founded decisions
- Pro-active attitude, excellent organization skills, and ability to manage multiple projects while delivering results on time.
- Proficient with MS Word, Excel, PowerPoint, and the management of spreadsheets.
For more information or a confidential discussion about this role please contact Michelle Mc Inerney.
091 706 717