ISO 13485 Auditor
ISO 13485 AUDITORS - ALL LEVELS - third party certification
United Kingdom, field based
£40,000 to £55,000 p.a depending on experience (trainee or qualified third party will access the higher salary) + company car, 10% bonus, Private medical, pension, 23 days holidays
SPONSORSHIP OFFERED FOR THE RIGHT PERSON
We are looking to recruit a registered Medical Devices Lead Auditor for a global certification body who provide audit, testing and certification services.
You will be required to plan and conduct medical Devices audits across a range of clients within the UK.
You must have at least 5 years relevant workplace experience of ISO 13485 ( ISO 14971, ISO 60601 is advantageous) and have worked for a notified body within the last 24 months ideally; or acted as a subcontractor to a certified body.
THE CLIENT WILL ALSO CONSIDER TRAINEE AUDITORS WHO HAVE AN EXCELLENT WORKING KNOWLEDGE AND UNDERSTANDING OF THE QUALITY SIDE OF ISO 13485;
YOU WILL HAVE MIN 4 YEARS EXPERIENCE WITHIN THE MEDICAL DEVICES SECTOR, WHERE YOU HAVE MANAGED ISO 13485 WITHIN AN ORGANISATION. A BIOLOGY OR SIMILAR DEGREE WILL SUBSITITUTE A PART OF THE REQUIRED EXPERIENCE.
- Conduct medical devices audits in accordance with established procedures, maintaining a high standard of service delivery that ensures effective customer relationships
- Ensure completion of all assigned work and relevant documentation to fulfil customer expectations
- Provide accurate and timely reporting as required to assist the planning and management of operations
- Manage personal schedule to work efficiently and to meet target chargeability requirements
In order to be successful in this role, you will be required to have the following skills and experience;
- Must be able to demonstrate and excellent working knowledge of medical device management systems, standards and medical device compliance/auditing techniques (Essential).
- Must be able to demonstrate a good knowledge of electro-medical devices (active devices); and/or sterilization and non active devices
- Good experience with Risk Management EN ISO 14971:2012
- Good knowledge of ISO 13485, MDD 93/42/EEC and their application
- Effective interpersonal skills; able to develop good working relationships with people at all levels (Essential)
- Willingness to learn and adapt to change - committed to continuous personal and professional development (Essential)
- Must have a detailed understanding of the relevant medical device regulations for with audits/technical reviews are being undertaken (Essential)
- Work experience in positions with significant QA or management systems responsibility (Essential)
- First degree, or equivalent vocational qualifications - i.e. BA/BSc, HND, Chartered Engineer, diploma etc (Essential)
This is a fantastic opportunity to become part of this large global organisation who offer career progression and attractive opportunities! If this sounds like you then please apply now!
For more information please contact Stephanie Taggart at Collective Recruit Ltd
Our client has appointed Collective Recruit as their resource partner & we are managing this role on their behalf. To apply for this position please click on the apply now button below. Your details as submitted by you, will only be forwarded in relation to this vacancy; by submitting your CV to us you are giving us express consent to provide our client with your full details if we believe your skills and experience meets with our clients criteria and/or need.
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