Description
I have an immediate opening for a Quality Systems Manager with a leading medical device company based in Dublin. This is a great opportunity to join a fantastic company with an excellent reputation.Working in a fast paced environment the successful candidate will have a strong engineering and Quality Systems experience in their career to date and will be responsible for managing a team on daily basis, reporting to stakeholders, ensuring compliance of Quality Systems etc.
Responsibilities:
* Lead Site Quality Management Systems including CAPA, Documentation and Complaints Management
* Drive continuous improvement and best practices in site Quality systems
* Co-ordinate Management Review and act as relief Management Representative
* Responsible for ensuring adherence to all internal and external regulatory requirements
* Manage Quality System audits.
* Maintain and follow up CAPAs
* Prepare reports on Quality System performance as required
* Be a key driver of cGMP practices within the Quality division
* Provide support for the ISO and ISO13485 Quality System
* Prepare and maintain documentation in compliance with the appropriate regulatory requirements
* Manage and develop the staff in the Quality Systems team through involvement, delegation and regular reviews of performance as established in IIGs.
* Drive key changes and continuous improvement in site Quality systems and procedures
Relevant experience:
* Third level degree in an Engineering or Science discipline
* At least 8 years post graduation experience in Quality environment with at least 5 years at a similar level
* Experience in management of Quality Systems in a Medical Devices/Pharmaceutical Industry
* Excellent knowledge of an ISO or 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 FDA requirements and managing FDA audits
* Demonstrated ability to lead, direct and influence people
* Six Sigma training desirable
* Excellent interpersonal and communication skills
* Strong planning and organizational ability
This is a fantastic opportunity to join an established company in a management position. This position offers excellent long term opportunities for career progression and development.If you are interested in hearing more about this opportunity please apply directly to this advert or contact Derek Sheridan on for further information.