Lead Medical Device Auditors

United Kingdom
£40000 to £60000 per annum
29 May 2018
26 Jun 2018
Chris Sowden
Contract Type
Full Time
Hyper Recruitment Solutions are currently looking for a Medical Device Auditors to join a leading Notified Body based in the United Kingdom. As a Medical Device Auditor you will be responsible for the planning and conducting of professional management system audits in accordance with the procedures of the Notified Body as well as participating in specific projects and business development activities.


Your duties as the Medical Device Auditors will be varied however the key duties and responsibilities are as follows:

1. You will conduct on site and desk based audits, review technical files and complete all required work related to Medical Devices as defined by the Medical Device Operations Manager.

2. The Medical Device Auditor will ensure that audits and Technical Files are reviewed for all Medical Device Products that are being authorized. This will involve project management of auditing teams, and of a personal schedule to ensure all work is completed by agreed deadlines.

3. You will be expected to conduct internal audits where appropriate to ensure internal compliance to relevant standards, as well as undertake professional development and training programmes to retain an active auditor accreditation, this may include providing training to staff members internally.

4. It will be your responsibility to support and represent the Notified Body with best practice and effective business development activities.


To be successful in your application to this exciting opportunity as the Medical Device Auditors we are looking to identify the following on your profile and past history:

1. Relevant degree in a Scientific/Technical Discipline.

2. Proven industry experience in the manufacture of Medical Device Products, with specific exposure to effective Medical Device Management Systems (ISO13485).

3. A working knowledge and practical experience with manufacturing Medical Devices in clean rooms/sterilisation product standards as well as key Medical Device guidelines (ISO13485, MDD 93/42/EEC).

Key Words: Medical Device | Class III Device | Notified Body | 98/79/EC | 93/42/EEC | IVD | In Vitro Diagnostics | Technical Files | Clinical Evaluations | High Risk Medical Devices | List A Devices | Compliance | Regulatory Compliance | Audit | Clinical Trial Reports | GMP | GXP | Design History File | Medical Devices | ISO14971 | ISO9001 | ISO13485 | Compliance | QA | Quality Assurance | Device Quality | QMS | Quality Systems | CAPA | Non Conformances | Audit | Deviations | Suppliers | Third Parties | Device Design Documents | Modifications | Life Cycle | IRCA | BSI | Lead Auditor |

Hyper Recruitment Solutions Ltd (HRS) is an Equal Opportunities employer who are certified by Investors in People for our talent development. We welcome applications for any applicant who fulfil the role requirements for this position. HRS is a company exclusively supporting the science and technology sectors, and is made up of a collaboration of recruitment processionals and scientists. We look forward to helping you with your next career moves.

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