Our client, a medical device company in Galway are currently looking to recruit a Senior QA Engineer for their site.
- You will provide support for all QA deliverables as part of the Atherectomy product transfer.
- Participate in internal and external audits and submission preparation and addressing any questions regarding these submissions. Post transfer, you will provide quality engineering support to operations, including leading and supporting root cause driven approaches to problem solving efforts for quality issues.
- You must think critically and make sound decisions.
- You will recommend and advise on quality aspects of systems, tools, equipment, suppliers and procedures to ensure compliance to our QMS.
- You will work within project teams to establish process controls that ensure the safety and efficacy of the product.
- You will have a high level understanding of product construction, features and uses at a competent level in order to make decisions on product acceptance standards.
- You must be focused on patient and customer and set high standards, instill operational excellence, and drive accountability.
- Participate in the deployment of continuous improvement initiatives within Plant 2 Operations and across the broader quality function.
- You will be required to liaise with departments, both internally and externally to build strong collaborative partnerships.
Experience / Qualifications
- Qualified person to Min level 8 Degree in Quality, Engineering or Technical/Science related discipline and desirably with min of 5 years relevant experience.
- You are a dynamic team player and can work effectively and proactively on cross-functional teams.
- You are experienced working in Medical Device industry in a Quality/Engineering or equivalent role.
- IT systems (SAP/QM) skills are desirable.
- You demonstrate strong oral and written communication skills as well as demonstrating good organizational, presentation and project management skills.
- You have the ability to communicate effectively at all levels and with all functions in the organization.
- Flexibility to travel <30% of time during product transfer is desirable.
For further information on this Senior QA Engineer role in Galway please contact Cliona O?Malley on 091730022 / firstname.lastname@example.org
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