QA Engineer (Software Validation)
Our client, a medical device company in Leitrim are currently looking to recruit a QA Engineer (Software Validation) for their site.
- Degree in Quality or Technical with emphasis on Medical Device Industry
- Computer Systems Validation experience
- Ideally 2-3 yrs experience in medical device or pharma industry
This involves but is not limited to:
- Required knowledge of GAMP.
- Completion of software risk assessments
- Knowledge and understanding of reading/generating IUS (Intended use statements), URS (User Requirements specifications), FS (Functional Specifications).
- Completion of Requirements Traceability Records.
- Generating Software Master Validation Plans, Software IQ's, OQ's, and PQ's.
- Participation in the new product introductions programmes to ensure that they are effectively introduced in accordance with the requirements of ISO 13845, in regard to software applications.
- Maintenance of the plant software master plan
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