I am currently recruiting for a Quality Engineer for a Medical Device company here in Sligo.
As a Quality Engineer, you will be responsible for:
- Assist with the development and maintenance of quality evaluation and control plans, and protocols for processing materials into finished products.
- Assist with the confirmation that corrective measures meet acceptable reliability standards and that documentation is complete and compliant with requirements.
- Generation and management of process deviations, non-conformances, supplier complaints, reworks, CAPA, complaints, rejects, and change notices.
- Liaise with suppliers and customers on quality-related issues.
- Issue of Product paperwork/lot records to manufacture.
- Drive continuous improvement and best practices.
- Review and approval of Material Specifications.
*Full job description available on request.
- A degree in a Science or Engineering discipline.
- A minimum of 2 years’ experience as a Quality Engineer within a Medical Device environment.
- Strong knowledge of ISO 13485 and FDA regulations 21CFR 820.
- Understand the general principles of ISO 14971.
- Internal/external auditing experience would be an advantage.
- Knowledge of Medical Device manufacturing environment including cGMP.
- Have MS Office Experience (Word, Excel, PowerPoint, etc.)
What You’ll Receive
- Competitive salary.
- 39-hour workweek (Monday to Friday).
- Educational assistance and professional development.
- Subsidised sports and social club.
- Employee wellbeing events.
For a confidential discussion and more information on this Quality Engineer role, please contact Emma Cawley.