Medical Lead Auditor

Job title: Medical Lead Auditor (Active Device)

Location : (Italy/UK )

Type: Permanent

A leading Notified Body within the European Union and UK is searching for a Medical Auditor to join their team, as they are foreseeing expansion.

With this opportunity, comes unrivalled access into a leading Notified body, with career progression, new challenges, Expansion of skill-set with different services and products and ability to work remotely.

As a Medical Auditor, you will be in charge of assessing the QMS of medical device manufacturers (Scheduled and unscheduled) and performing audits in accordance with the company’s standard procedure and providing high service delivery.

Key Responsibilities:

performing Audits of medical device manufacturers in accordance to Current QMS Standards and regulations requirements
Technical documentation handling within company’s standard procedure requirements, ensuring accuracy of documents and efficiency
In charge for direct technical support for clients- Handling of multiple versatile portfolios whilst performing planned audits for , documentation follow-up etc.
performing of Audits in a timely manner, whilst abiding to codes provided

Key Requirements:

AT LEAST 4 years of ACTIVE medical device experience within manufacturing, Design, R&D, Testing*
2 years of experience within quality management/ Quality management systems standards – e.g. SO 9001/ ISO 13485 comprehension *
Good comprehension of relevant safety protocols and standards
Certification body accredition including 17021-1
Relevant experience with medical devices/healthcare devices , to ensure comprehension and qualification e.r production, manufacturing, development etc.
willingness to travel up to 80% *
Fluent English