Our Client is the world’s leading inspection, verification, testing and certification company; they are recognised as the global benchmark for quality and integrity. With more than 95,000 employees they operate a network of more than 2,400 offices and laboratories around the world. They have an excellent new opportunity for an experienced Medical Devices QMS (ISO 13485) Auditor to join their global organisation.
The successful candidate will be responsible for planning and conducting professional management system audits in accordance with company procedures (desk based or on clients’ sites) in accordance with medical devices management systems standards (ISO 13485), you will maintain a high standard of service delivery that ensures effective customer relationships and ongoing business development whilst completing all chargeable work within the required budget and timeframes to ensure customer satisfaction and efficiency of the business.
An in-depth job brief will be discussed with short listed candidate
The candidate needs to have a range of electro medical devices/manufacturing experience, not just one; also, must have full experience or responsibility of an ISO 13485 system, with experience in positions with significant QA, Regulatory or management system responsibility; a knowledge corresponding to post-secondary education to equivalent work experience in one or several of the following areas - electronic, electrical mechanical and software technology medical devices. Knowledge of risk management EN ISO 14971:2012, excellent working knowledge of ISO 13485 and its application, a good knowledge of design, manufacturing of medical devices, the technology involved and their intended use plus Lead Auditor qualification, qualified to the latest version of the standard.
This is a national role, preferably covering the North area, but will accept applicants from other UK areas. The role will involve frequent overnight stays so a flexibility for this is essential. The role will be field based and therefore candidates must hold a full driving license.
The role offers a highly competitive salary plus company car, annual bonus, health cover and a contributory pension.
Please apply in complete confidence with your current CV