Closing Date: 27 Jan 17
Salary (£): 30,000 - 40,000
This is an excellent opportunity to use your hands on manufacturing experience, specifically if you are coming from a Microbiology background, in combination with existing auditing experience to become trained up as a Lead Auditor. ...
This is an excellent opportunity to use your hands on manufacturing experience, specifically if you are coming from a Microbiology background, in combination with existing auditing experience to become trained up as a Lead Auditor.
* Able to demonstrate an excellent working knowledge of medical device management systems, standards and medical device compliance/auditing techniques
* Able to demonstrate a good knowledge of sterilization and non-active devices
* Good knowledge of ISO 13485, MDD 93/42/EEC and their application
* Good knowledge of manufacturing of medical devices within a clean room and sterilization product standards
* Effective interpersonal skills; able to develop good working relationships with people at all levels
* IT literate i.e. competent in the use of MS Office applications and preferably experience of using large and complex databases
* Willingness to learn and adapt to change – committed to continuous personal and professional development
* Detailed understanding of the relevant medical device regulations for which audits/technical reviews are being undertaken
* Work experience in positions with significant QA, Regulatory or management systems responsibility
* Experience with Harmonised sterilization, clean-room and non-active medical device standards
* Experience with Risk Management EN ISO 14971:2012
* Industrial experience with medical device manufacturing that includes experience in the operation of the relevant sterilization processes
* Relevant technical application of the sterilization validation processes
* Medical device experience from auditing/work
* Experience auditing against recognised standards
* First degree, or equivalent in life sciences with microbiological aspect/modules or a microbiology degree
* Full driving licence for use in the UK
If you are interested please apply immediately.
4th Floor, 150 Leadenhall Street, London
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