Our client, an innovative and expanding medical device manufacturer here in Galway are looking to add a Senior Quality Engineer to their team as they grow and expand into their next building. They offer a diverse and inclusive workforce with a strong emphasis on a work-life balance.
- Managing team of Quality Engineers and Technicians providing technical support for the manufacture of existing products and support for the design and development of new products
- Establish, implement and maintain effective QMS requirements.
- Management of risk associated with the design, use, and manufacture of our client's 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 ISO13485:2016 & ISO14971:2007, and Medical Device Regulations, including MDD93/42/EEC, MDR/2017/745, SOR/98-282, 21CFR820, TGMDR & RDC 16/2013.
- Meaningful Collaboration with other functions in a team environment provides 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 the 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 which includes supplier audits & Non-Conformances.
Skills, Qualifications & Experience
- Engineering/Sciences graduate with a Minimum 6 years experience in a pharmaceutical/Medical Device environment
- Extensive knowledge of QMS and current international and European regulations/standards with respect to medical devices.
- Design for Manufacturing and lean manufacturing experience is a plus.
- 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