Quality Engineer - Sligo

Collins Mcnicholas Recruitment Hr Services

Sligo

Our client, a medical device producer, is seeking a Quality Engineer. In this role you will ensure that the company's QMS (Quality Management System) complies with all the requirements of current regulations, international quality standards (ISO 13485:2012, FDA CFR Part 820) and GMP requirements. Fully competent in the application of quality engineering tools and techniques with key emphasis on validation protocols (IQ, OQ, & PQ) & support the generation of DHF’s where appropriate. Individual with an experienced background in manufacturing within a controlled environment that can provide effective and responsive QA support to operations to meet their area objectives of quality and output. Individual shall support the internally Quality Management System auditing function and have exposure & involvement in supporting activities such as NCMR,s, change control & CAPA's. Individual shall have experience in Risk Management (ISO 14971). Individual shall provide and drive quality initiatives into the overall operational activities of the company and be a competent trainer. Individual shall be competent in authoring SOP,s and DHR,s and be experienced in final inspection and batch release. Education and Experience. The successful candidate will have at least three years’ experience in the life sciences sector, and a Degree in Quality Engineering/Engineering/ Science, or equivalent qualification. For further details, please contact Colin Byrne on 071-9142411 or email colin.byrne@collinsmcnicholas.ie. View all our jobs at www.collinsmcnicholas.ie.

3436 days ago