Description
Our client based in Drogheda are currently recruiting for the role of Quality Manager.Reporting to the Quality Director the successful candidate responsibilities will be to lead the Quality Team, providing a full range of quality functions to the business including,
establishing quality objectives, including those needed to meet requirements for the product, ensuring that they are established by relevant functions, and levels within the company.
The quality objectives shall be quantifiable and consistent with the Quality Policy.
MAIN DUTIES/RESPONSIBILITIES:
1. Effective and efficient running the Quality Assurance Department.
2. Establishing and Maintaining the Quality System.
3. Liaising with other departments on Quality Assurance issues.
4. Acting as Management Representative with specific responsibility for the Quality System.
5. Implementing and co-ordinating the corrective action process.
6. Assigning disposition to non-conforming materials.
7. Calibration Process.
8. Documentation control.
9. Release of Finished Product.
10. Statistical Process Control.
11. Approval of the Quality Manual.
12. Internal Quality Auditing Co-ordination.
13. Regulatory Affairs pertaining to the company Quality Systems and products,and post market vigilance.
14. Communication with the Notified Body on Quality and Regulatory issues.
15. Post Marketing Vigilance.
16. Conducting Management Review sessions.
17. QA related training activities.
Also:
1. Evaluating and reporting on the performance of the Quality Management System and the needs for improvement to Senior Management.
2. Promoting the awareness of regulatory and customer requirements throughout the organization.
3. Review the performance of the organisation's Quality System at a minimum of twice per year to ensure its continuing suitability, adequacy, and effectiveness.
REQUIREMENTS:
* Third level qualification in a Quality, Engineering or Science Discipline
* 10+ years 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 or ISO 13485 environment
* A working knowledge of FDA requirements and managing FDA audits
* Demonstrated ability to lead, direct and influence people
* Excellent interpersonal and communication skills
* Strong planning and organizational ability
This is an excellent opportunity to join an established and highly respected international company in a management role. If you feel you are a good fit and interested in hearing more please apply directly or contact Derek Sheridan on for further information.
Sthree UK is acting as an Employment Agency in relation to this vacancy.