Lead Auditor - Medical Devices

My client is currently looking to recruit for a Lead Auditor on contract, you will be joining a highly successful company. My client deals with auditing, testing, quality assurance, and certification. This role will be office based however they will considered home based after initial training is completed and it will develop into a position with minimum supervision.

Candidate will be required to have the following competencies;
* Assisting in the management of global procedural documents and quality management systems for Medical Devices
* Assisting in the preparation and maintenance of a global audit schedule for Medical Devices
* Working alongside an extremely highly regulated team performing key responsibilities;
* Need to clearly and demonstrate good working knowledge of ISO 13485 and Quality Management,
* Experience in meeting regulatory requirements .
* Conducting technical filing, along with planning and managing the key assessment set.
* Some travel to complete on site audits.

Lead Auditor's Requirements;
* Good working knowledge of ISO 13485 and ISO 14971
* Lead auditing experience
* Experience in CE Marking & FDA auditing
* Technical knowledge and experience in MDD 93/42EEC.
* Excellent communication and interpersonal skills have good leadership skills.

Keywords: Medical Device Auditor, Auditor, Auditing Quality Assurance, Quality Engineer, Medical Devices, Medical Electronics, ISO 13485, Quality Systems, West Sussex, CAPA, Medical Device Directive, QMS, Audit Design, 21 CFR part 820, Quality Control, Management, Six Sigma, , Quality Engineering Manager, ISO 14971, MDD, CMDCAS, IVD, Regulatory Affairs.

If you would like to arrange a time to discuss this role or if you have any questions about this position please feel free to send your up to date CV or contact me on 0207 758 7322.

To find out more about Real Staffing please visit www.realstaffing.com