About Your New Employer
You will work for a medical device engineering company based in County Sligo as a Quality Engineer.
This company are hiring for an experienced Quality Engineer to join their team on a permanent basis.
About Your New Job
As a Quality Engineer you will…
- Provide technical quality support to Project Manager, Design Engineers, Production manager and clients.
- Work closely with Engineering team and the client to establish and maintain compliant product specifications.
- Quality review of process validation plan, protocols, and reports.
- Co-ordinate and contribute to the generation and maintenance of compliant product risk management files.
- Issue, review, and release of lot records to manufacturing.
- Co-ordinate and review of testing and release of sterilise product.
- Quality review of SOP’s, Work instruction’s, template’s, Material specifications etc. to ensure compliance to applicable regulatory standards and cGMP procedures.
- Review and approve product change controls.
- Liaise with suppliers and clients on quality related issues.
- Perform an active role in the maintenance, further development and continuous improvement of the QMS.
- Support QMS as quality coordinator in investigation, root cause analysis, disposition, and corrective action of non-conformances & customer complaints.
- Perform CAPA reports.
- Support clients in product submission to applicable regulatory authorities.
- Conduct internal audits and compilation of associated documentation.
- Support and assist in the preparation for customer and surveillance audits.
What Skills You Need
- Minimum Degree in a Science or Engineering discipline.
- 3-5 Years’ experience working in the quality department for a medical device company.
- Strong knowledge of ISO 13485, FDA regulations 21CFR 820.
What’s on Offer
- Health Insurance
- Company Pension Scheme
- Educational Assistance
- Flexible Working Policy
What’s Next
- Apply now by clicking the “Apply Now" button or call me, Lauryn Flanagan on +353 91 455306
Or if the job isn’t quite right but you are looking for something similar, please get in touch. We also have multiple Temp, FTC and Contract jobs available.
