Medical Devices Quality Engineer with 3+ years experience in medical devices / pharma required by growing multinational in Galway city. You will be responsible for the continuous improvement of the organisation’s Quality Management System and get the opportunity to work on exciting new projects.
- Development and continuous improvement of the Quality Management system.
- Quality planning and new product introduction from a quality perspective.
- Establish and maintain risk management principles and methods.
- Maintain relevant documentation to comply with quality standards.
- Develop strong links with customer organization’s.
- Investigation of root cause and implementation of effective corrective actions.
- Overall responsibility for production GMP standards and compliance.
- Establishing inspection standards, sampling plans and test methods.
- Preparing and updating operations procedures and associated documentation.
- Supporting customer audits and surveillance audits.
- Conduct attribute test method validations.
- Support the validation activity for process changes and conduct the quality review.
- BSc. in Quality or Degree in Science / Engineering.
- 3+ years experience as a Quality Engineer.
- 3+ years experience in a medical device-manufacturing.
- Green belt problem-solving qualification preferred.
- Strong knowledge of FDA/ISO/MDD Quality systems for Medical device companies.
- New product introduction and manufacturing process transfer advantageous.
- Quality experience in component and device manufacturing desirable.
- Must be authorised to work in Ireland.
Please contact Emer Moore to discuss in confidence