Collins McNicholas currently have an exciting opportunity for a Quality Compliance Lead with one of their clients in the Mid-West Region. This role is a permanent position.
- Manages the Quality compliance function and provides leadership and direction to the Quality Compliance team.
- Oversees effective implementation of the Quality Management System (QMS) throughout the organization, including leading gap assessment and closure for any regulatory changes that have impact on the quality management system and actively coaching the organization to support the effective implementation and maintenance of a QMS.
- Supporting Top Management in the development and implementation of quality systems strategies and objectives.
- Maintains the site Quality Manual and Quality Systems Procedures and ensure contents are aligned to the global business process and applicable regulations/standards.
- Leads 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,
- Manage and monitor quality trending process for determining the effectiveness of applicable quality systems, develop processes and plans to address improvements as identified.
- Leads 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.
- Coordinates and supports effective management review process, ensuring all key quality performance trends are identified and dispositioned.
- Manages any 3rd party external audits and corporate audits through preparing the site; including managing the back room and supporting the front room.
- Manages the document control function to ensure all relevant QMS documentation is accessible and up to date following site change management process.
- Bachelor’s degree in engineering is required or an alternative bachelor’s degree with certification as a Quality Engineer (e.g. CQE)
- Must have minimum of 5 years of experience in Quality Engineering field
- Must have previously worked in a highly regulated industry, preferably Medical devices or pharma.
For a confidential discussion on the above role please contact Michael O’Leary on 061-512270