Medical Device Auditor

Department: Audit Team (Medical and Health Services)
Location: Home based once training completed
Role Overview:
This is a full time position with the successful candidate joining a friendly team of auditors. The job will be home-based after training has been completed at their Head Office at Fareham in Hampshire, and will involve planning and conducting audits of their client's products and systems as well as reporting results in accordance with company procedures. The primary focus of this role will be on auditing and testing active medical devices, so as to ensure compliance with regulatory and voluntary standards, although it will also be expected that the successful candidate will have the breadth of experience to support other members of the team in carrying out audits of non-active medical device companies.

Essential Candidate Requirements:
Degree qualified (e.g. BSc) in a relevant scientific subject, (e.g. Biology, Biochemistry, Chemistry, Microbiology, Pharmacy, Nursing, Physiology, Medical Engineering)

Experience required as follows:
Degree qualified (i.e. BSc) in a relevant scientific subject, (e.g. Electrical Engineering, Physics, etc.)

Previous experience in:
The medical device industry in a professional role (at least 3 years) in a company manufacturing active medical devices
Quality assurance within a company manufacturing active medical devices (at least 2 years)
Testing active medical devices Good knowledge of the Medical Devices Directives and ISO13485/ISO9001 standards Excellent communication and presentation skills (written and verbal) Willingness to travel throughout the UK and overseas.

Desirable Candidate Requirements:
Audit experience in quality management systems and medical device regulations especially if gained when working for a Notified Body
Product experience with non-active medical devices.
Fluency in a second European language