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 2,500 employees globally and revenues in the Billion +, this medical devices organisation remains one of the leading global Medical Devices organisations. 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 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 Senior Quality Manager (Site Quality Head sitting on the organisations SLT team) responsible for all Quality operations at the site with which HRM have been retained exclusively to manage.
- Ensure that all devices manufactured meet required quality specifications, through moulding, assembly, packaging, sterilization and release.
- Lead the following Quality functions: Quality Management Systems, Quality Engineering, Microbiology, and Validation.
- Manage and develop the staff in the Quality department through involvement, delegation, and regular reviews of performance as established in IIGs.
- Analyse customer complaints and modify processes/equipment/operator standards as necessary to eliminate defects.
- Responsible for ensuring adherence to all organisational, external and appropriate regulatory requirements.
- Become the contact person with NSAI, FDA and other Regulatory Bodies.
- Drive key changes and continuous improvement in site Quality systems and procedures.
- Be a key driver of cGMP practices across the site.
- Manage quality metrics across the site and ensure adherence to site quality targets.
- Liaise on a worldwide basis with global quality, engineering, R&D, marketing, and manufacturing staff.
- At least 8 years post-graduation experience in Quality environment with at least 5 years at a senior management level, within a Medical Devices/Pharmaceutical Industry.
- Excellent knowledge of an ISO 13485 environment.
- Experience in the preparation of Technical Documentation.
- Knowledge of Statistical Process Control and Six Sigma methodologies (Greenbelt Certification would be advantageous).
- Experience in CAPA system management.
- A working knowledge of regulatory requirements and managing regulatory audits.
- Demonstrated ability to lead, direct and influence people.
- Excellent interpersonal and communication skills.
- Strong planning and organizational ability.
To learn more about this role apply online or contact Shane Browne on + 353 1 6321865 for a confidential discussion.