My client a leading medical device company in Dublin is looking to hire a Quality Lead to become a key member of their Leadership team on a permanent basis.
The Quality Operations Leader will play a pivotal role in site process improvement activities and be the central point of contact for key customers. Duties will include management and approval of process validation studies, project management, application of SPC to current production processes and liaison with key stakeholders. Other Key duties will involve leading and directing the New product Quality Engineering team.
- To provide support for ISO13485 Quality System.
- Responsible for ensuring adherence to all external and appropriate regulatory requirements.
- Support production personnel in relevant continuous improvement activities (Six Sigma).
- Day to day Leadership/Management of New Product Quality Engineering Team.
- Manage and develop the team through involvement, delegation, and regular reviews of performance as established in IIGs (goals).
- Setup & Management of Key quality systems elements relating to direct production support such as the non- conformance system, incident reporting system and customer complaint analysis.
- Management of Quality control group and their activities to meet Project goals
- Driving key changes and improvements in the Quality assurance and control systems.
- Liaise with key external Suppliers and Customers.
- Ensure all CAPAs under your responsibility are completed in compliance with all regulatory and procedural commitments
- Prepare and Maintain documentation in compliance with appropriate regulatory requirements.
- Supporting key changes and improvements in manufacturing relating to product quality.
- GMP oversight and compliance of Production and Quality Engineering activities.
- Supporting key changes and improvements in manufacturing relating to product quality
- Provide Quality Engineering Support and Leadership for Key Clinical Builds in FY21
- Develop and implement validation strategy for IQ/OQ and PQ requirements.
- Ensure verification activities undergo test method validation to ensure consistent operation of the test equipment and results for the intended use
For this role we are looking for candidate with 5+ years of experience in a similar position qualified to a minimum of NFQ Level 8, preferably a Science degree incorporating Quality Assurance. Experience in managing a team. You will have a strong knowledge of ISO standards and FDA.
For further information on Quality Lead role in Dublin please contact Clara Burke on 086 8168273 / firstname.lastname@example.org
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