A Major Medical Devices Company in Tullamore, County Offaly, Ireland is seeking to recruit a suitably qualified person for the following post:
QUALITY ENGINEER (TEMPORARY)
Working in conjunction with Engineering Departments, co-develop design verification & validation protocols for new products (or transfer) and for change on existing products, conduct design verification & validation studies, review and approve protocols, studies, and perform general oversight responsibilities for validation process, for both equipment and processes.
Conduct detailed root cause analysis and define corrective and preventive actions for NCR
Conduct Internal audits and Supplier audits against schedule
Develop Inspection plans for Incoming inspections, Inprocess and Final QA inspection for products manufactured
Detailed Review and approval of Risk Managements files
Review and Approval of Change Orders associated with components and manufacturing process,
Lead quality problem investigations using proven quality tools and providing training as necessary to staff with respect to problem resolution, process or procedure changes.
Ensure that requirements laid down in the quality manual and standard operating procedures are adhered too, and provide advice and guidance to other departments on quality related aspects.
Provide Operational QA Support for products and process.
Ensure correct and timely disposition of MRB material.
Degree in Quality, Engineering or a Science discipline.
3-5 years' experience at quality engineering level within a regulated industry, preferably the Medical Device Industry
Demonstrable knowledge of FDA 21CFR820 and/or ISO 13485 regulations
Familiarity with use of ISO 14971:2007 an advantage.
Willingness to travel to other Company sites as part of duties.
Salary: A very attractive Salary/Benefits Package is on offer
If interested in applying for this post, please email your CV in Word Format to:
For informal enquiries, please ring Christy on 087-9473404