Quality Systems Engineer– Medical Device – Co Clare
A great new job opportunity has arisen for a Quality Systems Engineer
Medical Device experience preferred – pharmaceutical or other highly regulated industries will be considered also
Brief Summary of Requirements: – (full job description available on request)
- Supports effective implementation of the Quality Management System (QMS) throughout the organization closure for any regulatory changes that have impact on the quality management system.
- Maintains the site Quality Manual and Quality Systems Procedures and ensure contents are aligned to the and applicable regulations/standards.
- Supports and manages site CAPA program including, collecting and analyzing data to appropriately and efficiently identify ‘Root Cause’ and ensuring ‘Verification of Effectiveness’ plans are comprehensive, to facilitate overall improvement in performance of key quality system elements,
- Supports quality trending process for determining the effectiveness of applicable quality systems, develop processes and plans to address improvements as identified.
- Supports site internal audit program, including conducting internal audits and ensuring that audits are completed on time and in full and that all observations are being addressed by owners as appropriate.
- Supports any 3rd party external audits and corporate audits through preparing the site; including supporting the front and back room.
- Bachelor’s degree in Engineering, Technology or Science is required or an alternative Bachelor’s degree with certification as a Quality Engineer (e.g. CQE)
- Must be familiar with Microsoft Office Suite
- Must have minimum of 3 years of experience in Quality Engineering field
If you are looking for a new job in the Limerick / Clare area or looking for a move back to Clare please feel free to contact Deirdre for a confidential discussion