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