Exciting new opportunity for a QA Engineer (Validation) with a Leitrim based company. The ideal candidate will have 2+ years experience working as a Quality/Validation Engineer within the Medical Device/Pharma environment. A Senior position may also exist for a candidate with a minimum of 6 years' experience. This is a permanent full-time role.
Role of this position
- Ensuring that product introductions & change controls are effectively managed in accordance with the requirements of ISO 13485 & MDD 93/42/EEC.
- Participation in the new product introductions programmes to ensure that they are effectively introduced in accordance with the requirements of ISO 13845.
- Generation of Product Technical Files & associated studies in accordance with MDD 93/42/EEC when appropriate.
- Completion of Validation Programme - Risk Analysis, VMP, IQ's, OQ's, PQ's as required according to procedure QAP 030 and other related procedures
- For a Senior QA Engineer (Validation) - Management of QA/Technical/Associate/Engineers (Validation), as applicable).
- Degree in Engineering/Manufacturing/Quality with emphasis on Medical Devices/Biomedical.
- Ideally 2+ years previous experience as Quality/Validation Engineer in Medical Device/Pharma Environment.
- An Associate position may exist where there is limited experience.
- A Senior position may exist for a minimum of 6 years' experience.
Please call Michelle Galvin today for further information on 091 373 938 or email: firstname.lastname@example.org
CareerWise Recruitment (In Search of Excellence)