Our client, a medical device company in Limerick are currently looking to recruit a Quality Engineer for their site.
The Quality Engineer is accountable for supporting the BDBI site, such as operational effectiveness including the ongoing support of the Quality Management System for the BDBI site.
The Quality Engineer focuses on the creation of quality processes and procedures at the BDBI site which support production control, process control & validation, supplier management and technology transfer based on industry and best practices.
Generate NCRs and CAPAs for defects, deviations and non-conformities on-site and on clinical sites too, ensuring effective closure.
Support calibration and maintenance programs onsite.
Work cross functionally across all departments, supporting the development of relevant
Help drive changes in procedures and processes in relation to ISO13485 and CE Registration.
The Ideal Candidate
As a Quality Engineer you will be a key member of the Quality Department. Principle tasks will include:
- Compiling metrics to demonstrate the effectiveness of the Quality Management System
- Creating and revising quality procedures and forms
- Managing the Deviation (Non-Conforming Report (NCR)) system in line with corporate requirements
- Establishment or review of records established through NCR’s, Deviations, CAPA’s, Change Controls and customer complaints
- Participate in cross functional teams in dealing with NCR’s, Deviations, Change Controls, CAPA’s and Complaints
- Performance of audits (internal audits and supplier)
- Reviewing and approving protocols and reports associated with process validation and qualification of new equipment
- Provide QA support to Procurement process, when assessing and qualifying Vendors
- Share expertise and knowledge with other QA Representatives
- Promote and support quality, compliance and validation activities
- A minimum of 2 years of experience working within a quality function.
- A minimum of 2 years of experience working in a FDA or ISO regulated environment.
- A minimum of a bachelor’s degree is required.
For further information on this Quality Engineer 12-month Contract role in Limerick please contact Orla on 086 0449473/ firstname.lastname@example.org
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