Telephone: 086 8395533
Our client, a medical device company in Westmeath is currently looking to recruit a Quality Engineer for their site.
- You will be a key contributor and team player in the provision of Quality assurance and compliance to engineering projects and services.
- You will plan and execute validation IQ, OQ & PQ protocols and reports to FDA requirements.
- You will co-ordinate the completion of risk management, process capability and statistical assessments and will provide quality engineering support to resolve process problems.
- You will write, review and update compliance documents, procedures, protocols, reports and relevant documents required in the course of achieving Quality compliance.
- You will develop and maintain a deep understanding of processes and products within areas of responsibility in order to support process improvements, changes and projects.
- You will support non-conforming investigations using robust root-cause analyses tools.
- You will liaise with cross functional teams, utilizing influencing skills where appropriate, to achieve assignments on time.
- You will establish and develop strong and effective working relationships at all levels to ensure maximum effectiveness.
- We are looking for a qualified person to third level degree in a relevant Quality/Engineering/Science related discipline and preferably with 4-6 years relevant experience in a medical devices or similar regulated environment.
- You are a results driven and dynamic team player and can work effectively and proactively on cross-functional teams.
- You are knowledgeable in Quality Systems, validation standards, policies, procedures and methodologies.
- Knowledge, understanding and implementation of GAMP5 is an advantage.
- You are experienced with practical working knowledge of statistical data analysis and quality improvement tools and techniques.
- You must think critically and make sound decisions.
- You must be focused on patient and customer and set high standards, instill operational excellence, and drive accountability.
- You have excellent written, documentation, and oral communication skills and are fluent in English, both written and spoken.
- You have excellent organizational skills and have the ability to prioritize and work effectively on multiple projects.
For further information on this Quality Engineer role in Westmeath please contact Bimi Felix on 086 8395533 / email@example.com
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