Role: QA Engineer (Validation)
Location: Carrick on Shannon, Leitrim
Benefits: Competitive salary, Bonus, pension, and healthcare
Company:
Work with the largest employer in Leitrim, specializing in manufacturing catheters in-house. The company features dedicated cleanrooms for customers and is highly specialized. They typically promote around 100 employees per year through projects, individual plans, goal setting, and leadership training.
Responsibilities:
1. Ensure effective management of product introductions and change controls in accordance with ISO 13485.
2. Participate in new product introduction programs, ensuring they meet ISO 13485 requirements. Generate Product Technical Files and related studies.
3. Complete validation programs including risk analysis, VMP, IQs, OQs, PQs as required by procedures QAP 030 and others.
4. Adhere to plant safety and health & safety requirements, taking responsibility for aspects of the OH&S system under your control to ensure safety of yourself and others.
5. Be aware of potential environmental impacts of your work and the implications of non-conformance.
6. Contribute to energy performance improvements through conservation (lighting, equipment, air conditioning, etc.).
7. Participate in continual improvement activities of OH&S, environmental, and energy management systems by providing feedback, suggestions, and reporting incidents promptly.
Qualifications:
* Third-level qualification in science, biomedical, or engineering is desirable.
* At least 2 years of experience in a similar role within the medical device industry.
Does this sound like your next career move? For more information, forward your application or contact me at 087 0612325 or via email at thomas.gallagher@lifescience.ie.
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