Site Quality Manager
This leading Medical Devices organisation has been a long time investor here in Ireland with operations in Ireland since the 1960’s. Employing in the region of 50,000 employees globally and revenues north of 10 Billion per annum, this medical devices organisation remains one of the largest global Medical Devices organisations globally. Since its introduction to Ireland, this innovator has proceeded to continuously invest in this country including investments in additional manufacturing and research sites across Ireland. One of the organisations primary plants based in North Leinster is currently undergoing significant investment and change and has transformed its operations in Ireland through strong leadership, continuous innovation and demonstrating the importance of this site to the organisations global manufacturing operations. At present, a requirement exists for a Quality Leader to Head up all Quality responsibilities including team management for the site and sitting as part of the organisations’ Site Leadership Team.
- Manage and Implement Global Quality Objectives at the site level
- Ensure that all devices manufactured meet required quality specifications, through moulding, assembly, packaging, sterilisation and release
- Manage and develop the staff in the Quality department through involvement, delegation, and regular reviews of performance as established in IIGs
- Drive Quality Improvement Plans at the site
- Responsible for ensuring adherence to all organisations, external and appropriate regulatory requirements (e.g. ISO, FDA)
- Manage quality metrics across the site and ensure adherence to site quality targets
- Liaise on a worldwide basis with quality, engineering, R&D, marketing, and manufacturing staff
- Member of the Site Leadership Team, with the responsibility to support key initiatives and development strategy for the site
- Acting as Management Representative with specific responsibility for the Quality System. Manage the Batch Release Process to meet Supply Chain Requirements Analyse customer complaints and modify processes/equipment/operator standards as necessary to eliminate defects
- Implementing and coordinating the CAPA process
- Assigning disposition to non-conforming materials
- Managing quality spend budget and challenging spend where appropriate
- Manage updates to the Quality Manual
- Internal Quality Auditing Co-ordination
- Communication with the Notified Body on Quality and Regulatory issues.
- Conducting Management Review sessions.
- Support Sales and Marketing Customer Centricity Objectives
- 10+ years’ experience in Quality environment within a Medical Devices/Pharmaceutical Industry
- Excellent knowledge of the ISO 13485 Quality Standard
- A working knowledge of FDA requirements and managing FDA audits
- Demonstrated ability to lead, direct and influence people
- Excellent people management and communication skills
- Strong planning and organizational ability
To discover more about this opportunity, apply now or contact Shane Browne at HRM on +353 1 6321865 for a confidential discussion.
Salary: On Application