Medical Devices Auditor Job (Active Devices)

Andrew Bolton at CK Science is currently looking for a Medical Device Auditor to join a world leading auditing & certification consultancy, which provides specialist services to the medical device & related technology industries. This role will initially be based between their sites in Hampshire & Germany during the training period, with the option to be field based thereafter.

Responsibilities:

As a Medical Device Auditor, you will be involved in:

  • Planning & conducting audits (ISO, IVD, MDD, FDA, MRA, CE Marking) of customer’s active medical devices, facilities & quality management systems (QMS)
  • Testing of active medical devices in line with relevant electrical standards
  • Reviewing & approval of technical file / design dossiers, significant change notifications and other technical documentation.

Within this role, you will be required to travel to customer sites within the UK, Europe, USA & Asia.

Qualifications and skills:

To be considered for this Medical Device Auditor role, you will have the following:

  • Degree in electrical engineering, physics or a related discipline (or equivalent)
  • Working knowledge of quality systems relating to medical devices (CE Marking, ISO 13485:2003 & ISO 9001:2008
  • Demonstrated experience involved in audits (internal or external).

Knowledge of another European language and/or experience as an Auditor in Medical Devices would be advantageous, but it is not essential.

Benefits:

This Medical Device Auditor role is an outstanding opportunity to join a leading auditing & certification consultancy for the medical device industries. In return they offer a competitive salary & excellent benefits.

How to apply:

Apply online for this role

For more information or to apply for this Medical Device Auditor role please contact Andrew Bolton on 01438 723 500 or email abolton@ckscience.co.uk. Please quote reference ST23810 in all correspondence.

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