Auditor – Medical Devices

Auditor – Medical Devices

Our client, a leader within worldwide certification, currently requires an experienced & qualified Lead Auditor to work on a number of parts of the regulatory process in relation to the medical devices directive 93/42/EEC. They are looking for a specific individual that has experience in the area of medical devices ideally with in depth experience of the associated manufacturing processes.

Main Duties:

As an Auditor you will have overall client management responsibilities and will be competent to review critical design data including risk analysis, labeling, clinical investigation data and post market surveillance information and to prepare recommendations for CE certification. You will also participate in the audit activities as a technical expert. As a technical expert you will assess device manufacturer’s technical files & design dossiers as well as their in-house quality system

The job will entail some travel (average 6-8 weeks annually) to represent the company and to visit manufacturers to perform the tasks.

Requirements:

The Auditor must have an in depth knowledge of the medical devices directive 93/42/EEC & supporting guidance documents (MEDDEVs etc) ideally knowledge of other national regulation, e.g. Health Canada, Japan etc. The individual must be an experienced lead auditor in a medical devices environment (first/second/third party audits will be considered).

The individual must be capable of representing the company in a professional manner and dealing with Intertek employees and clients avoiding confrontation where ever possible. The individual must be a team player and a ‘finisher’ capable of providing required information on time and in full.

Location: Buckinghamshire
Salary: £42,000 – £54,000+ car + excellent benefits