Medical Device Lead Auditor – (Active Devices)
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 Lead Auditor (Active Devices) to join their global organisation.
The successful candidate will be responsible for planning and conducting audits against the manufacturing of medical devices, in accordance with ISO 13485, MDD 93/42/EEC and MDSAP standards, enabling the delivery of assessment and certification services that meet customer requirements and appropriate accreditation standards.
You should be a qualified Lead Auditor qualified to the latest version of the standard with an excellent working knowledge of ISO 13485, MDD 93/42/EEC and their application and will be able to demonstrate good manufacturing and technical knowledge of electro-medical devices (active devices) and their relevant harmonized standards. Experience of conducting MDSAP audits or standalone Technical File reviewer would also be advantageous.
Applications are welcome from any on site qualified medical device lead auditors working for a notified body or as a Technical File reviewer or as a mixture of both. The successful candidate will have a strong background in the medical device industry and ideally 4 years working experience in the medical device related industry or activities including the relevant production technology. This must include at least 2 years in a technical, quality or manufacturing role; the application of the device in health care services with patients; testing devices; performance testing; evaluation studies or clinical trials of devices and must be able to demonstrate an excellent working knowledge of medical device management systems, standards and medical device compliance/auditing techniques.
An in-depth job brief will be discussed with short listed candidate
The role offers a highly competitive salary plus company car, annual bonus, health cover and a contributory pension.
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