Our client, an Innovative and Expanding Medical Device Manufacturer here in Galway are looking Quality Manager to their team as they grow and expand into their next building.
This role is a key member of the Quality function includes:
- Managing team of Quality Engineers and Technicians providing technical support for the manufacture of existing products and support of design and development of new products
- Establish, implement and maintain effective QMS requirements.
- Management of risk associated with the design, use and manufacture of Phenox devices.
- Reporting to Senior Management on the performance of the QMS and ensuring the promotion of awareness of regulatory requirements throughout the organization.
- Ensuring compliance to regulatory requirements appropriate to the quality management system; medical device ISO standards, including ISO1348521CFR: 820 and Medical Device Regulations.
- Meaningful Collaboration with other functions in a team environment providing Quality input & leadership.
- Provide guidance to project teams and engineers in developing protocols, reports, procedures, deviations and change requests for identified projects
- Provide technical support for the manufacture of existing products and the growth and development / transfer of new products / technologies.
- Ensure the QMS including document control system, calibration system, internal audits and NCR/CAPA system is maintained.
- Monitor the suitability and effectiveness of the QMS and assure compliance with current US and international regulations and ISO standards.
- Actively participates in specification development in relation to design input development
- Manage and oversee key elements of Batch Release
- Manage supplier approval and qualification of new/revised items including supplier audit & Non-Conformance.
- Engineering/Sciences graduate with Minimum 5 years experience in a pharmaceutical/Medical Device environment
- Minimum 2 years’ experience in Quality Management or Senior Quality position as a personnel manager.
- Extensive knowledge of QMS and current international and European regulations/standards with respect to medical devices.
- Excellent interpersonal and communication skills with good leadership abilities; high level of self-motivation
- Demonstrable ability to work in a multi-disciplinary, regulated environment
For more information or a confidential discussion about this role please contact Michelle Mc Inerney.
091 706 717