Medical Device Auditor
Job Title: Medical Device Auditor
Company: TÜV Product Service Limited
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 our Head Office at Fareham in Hampshire, and will involve planning and conducting audits of clients’ products and systems as well as reporting results in accordance with company procedures. You will ensure compliance with regulatory and voluntary standards, assisting clients to maximise the value and effectiveness of their quality management system.
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:
- The medical device industry in a professional role (preferably more than 5 years)
- Quality assurance within a company manufacturing non-active medical devices (preferably more than 4 years)
- Several different types of non-active medical device
- A management position
- Good knowledge of the Medical Devices Directives and ISO13485/ISO9001 standards
- Excellent communication and presentation skills (written and verbal)
- Willing to travel throughout the UK and overseas
Desirable Candidate Requirements:
- Product Expertise in class IIb or III non-active medical devices
- Audit experience in quality management systems and medical device regulations especially if gained when working for a Notified Body
- Knowledge of Canadian Medical Device Regulations
- IRCA registered
- Fluency in a second European language
TÜVPS – Further information:
TÜV SÜD Product Service is the leading provider of medical device certification services with offices throughout the world. As a European Notified Body (number 0123) and an accredited body for all relevant Directives and quality system standards, we offer auditing and certification services for all types of medical device against the three medical device directives, ISO9001, ISO13485, CMDR and audits on behalf of the US FDA and Taiwanese authorities.
For further information, contact : Sandie Peacock, HR Administrator, TÜV Product Service Limited, TÜV SÜD Group, Octagon House, Concorde Way, Segensworth North, Fareham, PO15 5RL. Telephone: 01489 558227. Facsimile: 01489 570586. Email: speacock@tuvps.co.uk.
