Ref. no.: JO-1106-232541
Job description:
Our client, a multinational medical device company, currently has a vacancy for a Quality Engineer. This is a permanent role based at their Limerick facility.
We are interested in hearing from candidates with the following background and experience:
Third Level Qualification in Science or Engineering. Additional qualification in Quality/Validation/Statistics would be a distinct advantage.
Proven knowledge and experience (min 4 years) of working with ISO13485:2003, ISO14971: 2000, the Medical Device Directive and the FDA QSR including 21 CFR Part 820 and 21 CFR Part 11, ideally gained in the medical device industry.
Proven knowledge and experience of all aspects of Validation including Process Validation and Software Validation
Good working knowledge of statistics.
Strong interpersonal skill with the ability to communicate effectively at all organisational levels.
The ability to challenge thinking/opinion/actions in light of ensuring Company Quality Systems and Processes are adhered to.
High attention to detail in all aspects of the role.
Excellent organisational skills.
Proven problem-solving skills.
High self motivation.
Good working knowledge of Microsoft Office.
The successful candidate will provide Quality Engineering support to Manufacturing Engineering, Production, Product Development, Product Transfers and Operations. This includes, but is not limited to, providing support to process validation, change requests, non-conforming product issues, Company Corrective and Preventive Action program, Design and Process FMECA, and associated Quality System Documentation. There is a requirement to travel on company business.
For a full Job Spec and to find out more about this role please call Ciara at 01 2784671 or email your CV in the strictest confidence to cbyrne@thornshaw.com.
