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Quality Engineer III
Our client, a medical device company in Galway are currently looking to recruit a Quality Engineer III for their site.
- You will take a lead role in the planning and the execution of process validation activities for new products, technology transfers and improvement projects.
- You will play a key role in providing Quality input into new product development, process improvements and change control.
- You will support the characterization and risk assessment of manufacturing processes and associated equipment.
- You will work with project team members to establish process controls that ensure the safety and efficacy of the product.
- You will be an extended team member on PDP projects, representing the Quality Engineering function.
- You will liaise with cross functional team members, developing strong partnering relationships with these groups.
- You will develop and maintain expert, up to date knowledge of developments in regulatory compliance requirements for product design, development, validation, technology transfer and commercialisation activities.
- You will lead and support root cause driven approaches to problem solving efforts for quality issues.
- You will use and establish analysis techniques and other quality tools to aid decision making.
- We are looking for a person qualified to a Level 8 Third Level Degree in Science, Engineering or related discipline.
- You are a dynamic team player and leader and can work effectively and proactively on cross-functional teams.
- You are experienced with the ability to be self-directed and to effectively interface with various levels and functions within the organization.
- Ability to recognize, anticipate and innovatively create solutions to issues and problems in a timely manner is desirable.
- Having broad technical expertise and knowledge of interrelated quality function disciplines and a high level of aptitude in QE/QA principles and methodologies is advantageous.
- A good working knowledge of process validation requirements would be beneficial.
- Some experience or background in combination or pharmaceutical products would also be beneficial.
- You are a good communicator and fluent in English, both in writing and speaking.
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