Quality Engineer – Medical Devices
A Medical Device multinational is seeking an experienced Quality Engineer with at least three years experience coming from a Medical Device or Pharmaceutical background to join their team. You will be responsible for the continuous improvement of the organisations Quality Management System.
- 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 Mary-Ann Keena to learn more
+353 (0) 83 0220666