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EMEA Quality Medical Device Auditor

SIRE Life Sciences®

Netherlands, zagranica

SIRE Life Sciences®

EMEA Quality Medical Device Auditor

Location: Netherlands

SIRE Life Sciences® is the market leader in life science recruitment. We believe the recruitment market needs to gear up in technology and continues innovation. We like technology, in a life science market driven on science, we couldn’t stay behind; we drive Recruitment Science. Investing a majority of our turnover in technology enables us to use unique Resource Technologies. By using highly advanced algorithms, we enable our team of Resource & Data Strategists© to maintain the most advanced, detailed and complete Life Sciences network in Europe. This big data enables us to work Reverse Recruitment©: we first analyze the market in-depth before we go out to the market. Because we analyze the whole market, we can compare facts and data. This enables us to do Facts & Big Data Recruitment©, making sure we, or better yet, you find the right career!

THE COMPANY

Our client is a professional Medical Devices organization, based in Netherlands.

They are a Life Science company focused on Medical device Industry and regulations within the Industry. They are looking for a QA specialist that can audit and assess their Medical Device plants across Europe.

ROLE DESCRIPTION

As the new specialist you will travel through the Netherlands and EMEA region to Assess and analyze current situations as a normal Auditor/assessor would do. In order to be 100% compliant it is your job to make every plant and office conform the regulations of the Medical Device ISO 13485 and risk management ISO 14971. By understanding the business and environment of the company and their challenges you’ll be able to help them improve their performance and overall results. You will travel and take pride in an extremely rewarding role within the medical devices world and have an effect on the organisation and Medical environment.

RESPONSIBILITIES

Your responsibilities would constantly be working with Directors and Managers of different sites and work towards compliancy with Medical Device regulations. It is your task to find improvements in the current QMS, both in the end products of the sites as in the process and manufacturing activities. The position is home based but as the new EMEA auditor you will travel up to a maximum of 75-80% during your work to other sites. Traveling is an essential part of the role that could include overnight stays if needed.

REQUIREMENTS

• Working knowledge of ISO 13485, ISO 14971, MDD
• Experience and knowledge in MDD Active Devices/Software Devices IEC 62304, 62366, 60601
• Gained experience with hands-on engineering
• 5 years experience in Medical Device environment
• You will be trained for the first Months in the specific regulatory knowledge about the devices and company
• Willing to travel and take pride in an extremely rewarding role within the medical devices world

Are you interested and do want to apply for this role, please fill out your application via the apply button below and contact Jeroen Evertsen.

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SIRE Life Sciences®

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