Overview
Lead Auditor Jobs in England – UK at EPM Scientific
Title: Lead Auditor
Company: EPM Scientific
Location: England – UK
Category: Healthcare
Medical Device Auditor
Have you got what it takes to succeed The following information should be read carefully by all candidates.
Job type:
Permanent
Location:
Home Based (Europe)
A leading global Medical Device Notified Body is now looking for Medical Device Auditors to join their growing team in Europe. You will play a key role in the company’s growth strategy and business success. In addition, you will be able to make an immediate impact on their European operations with leading Med Tech manufactures.
Key responsibilities of the Medical Device Auditor include:
Perform regulatory audits of Clients (scheduled and unannounced), as well as evaluations of regulatory submissions which include Technical File Review, according to EU directives (MDD/MDR), ISO
13485 and MDSAP
Reviewing corrective actions, preparing reports and audit documentation for submission to the certification committee of the Notified Body
Provideproject managementfor Europe-based Clients. This will include the issuing of quotes, coordinating multiple projects, coordinating audit team and interacting directly with the customer
Key requirements of the Medical Device Auditor include:
The ideal candidate should have a strong background in the production, validation, engineering or development side with Medical products
Direct involvement in the Quality Management System (QMS) of a Medical Manufacturer. Experience in either active or non-active products
At least 4 yearshands-onmedical device experience in order to qualify for Notified Body Auditor status
Regular travel across the Europe is required
University degree in Engineering or Sciences;
Biomedical, Electrical, Industrial, Biology, Chemistry or Physics
