QC Team Leader

They are looking for a QC Team Leader to manage the activities of a defined team of QC personnel at their site in the North West.

Responsibilities include:

* Responsible for recruitment, development and training of all QC personnel.
* Lead Master Validation Planning activities
* Develop and utilise DFMEA/PFMEA and other QC risk analysis techniques in order to minimise potential risk during development/implementation activity.
* Administer Final Product Sterilisation Release and manage document archives of all related documentation
* Be responsible for the introduction and correct use of statistical QC methods into the production environment, and provide technical resource for production team on relevant IQ/OQ/PQ protocol issues.
* Ensure compliance with all Documented Quality system, FDA QSR's and ISO 13485/9001 requirements during day to day and assigned audit/CAPA activities
* Develop and utilise DFMEA/PFMEA and other QC risk analysis techniques in order to minimise potential risk during development/implementation activity.

To be considered for this role, you will need to have:

* Administer Final Product Sterilisation Release and manage document archives of all related documentation
* Be responsible for the introduction and correct use of statistical QC methods into the production environment, and provide technical resource for production team on relevant IQ/OQ/PQ protocol issues.
* Ensure compliance with all Documented Quality system, FDA QSR's and ISO 13485/9001 requirements during day to day and assigned audit/CAPA activities
* Develop and utilise DFMEA/PFMEA and other QC risk analysis techniques in order to minimise potential risk during development/implementation activity.
* Proven staff supervisory capabilities and project management experience
Degree level qualification or equivalent in an Engineering or Science based discipline
* Alternatively - 5 years experience in a quality role within a regulated industry with a minimum of 2 years experience in a managerial position may be considered in lieu of the academic qualification
* Must have an engineering background in manufacturing with proven ability to interpret engineering specifications and procedures
* Must be PC literate and familiar MRP/JDE business software solutions
* Experience of corporate, ISO and FDA assessments

This is an amazing opportunity to join a multi national organisation with a huge scope to progress quickly in your career. The salary will be up to £45K (neg) plus benefits.

If you feel that you have the relevant skills and experiences required, please respond with an updated CV call 0207 758 7311 for further details I would be happy to discuss.

Keywords:, Regulatory Affairs,QA,QCActivities, GMPs, GxP's, SOPs, Systems, Quality Management, Quality Assurance, Quality Management Systems, implants, trauma devices, ISO 13485/9001To find out more about Real please visit www.realstaffing.com