Description
My client, a leading medical device company based in Dublin, have an immediate opening for an experienced Quality Engineering Manager.Duties will include management and approval of process validation studies, project management, application of SPC to current production processes and liaison
with key stakeholders. This is an excellent opportunity to join a highly respected Medical Device company in the Dublin area.
Responsibilities
* To provide support for ISO9000/ISO13485 Quality System.
* Responsible for ensuring adherence to all external and appropriate regulatory requirements.
* Become a key member of the Quality Leadership Team.
* Support production personnel in relevant continuous improvement activities (Six Sigma).
* Day to day Leadership/Management of Quality Engineering Team. Manage and develop the team through involvement, delegation, and regular reviews of performance as established in IIGs (goals).
* Management of Key quality systems elements relating to direct production support such as the non- conformance system, incident reporting system and customer complaint analysis.
* Management of Quality control group and their activities.
* Driving key changes and improvements in the Quality assurance and control systems.
* Liaise with key external customers.
* Prepare and Maintain documentation in compliance with appropriate regulatory requirements.
* Supporting key changes and improvements in manufacturing relating to product quality.
* GMP oversight and compliance of Production and Quality Engineering activities.
Requirements
* A minimum of 5 years work experience in anISO orISO13485 environment, coupled with a background in Medical Devices/Pharmaceutical Industry.
* Experience in the preparation of Technical Documentation.
* At least 3 years supervisory experience.
* 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.
* Experience in process validation, Sterilisation and working in a clean room environment would be advantageous.
* Proven ability of working in a cross-functional team environment.
* Excellent interpersonal and communication skills and high level of computer literacy.
If you feel that you would be a good fit for this role please apply directly or contact Derek Sheridan on for further information.
To find out more about Real please visit www.realstaffing.com