Senior QMS Expert
Location: NetherlandsSIRE 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 Noord-Holland Netherlands.
They are a global leader in Medical Technology in order to make Healthcare better. Their range of product varies and are distributed in more than a 100 countries. You will take part of a global structure and initiative to improve global healthcare where you will take a key position to improve the companies and thus global healthcare better.
ROLE DESCRIPTION
The company is now looking for an enthusiastic Senior QMS specialist for the European Region within the EMEA department. You have experience in EU Medical Devices with ISO 13485 and want to make a difference in global healthcare? As the new specialist you will be responsible for governance and centralization of the Quality Management Systems of all company distribution sites within Europe.
RESPONSIBILITIES
• Perform a gap analysis and make an according plan to successfully be compliant and achieve ISO 13485 certification
• Manage internal QA audit procedures, conduct/support trainings and will follow up on opportunities to improve through Corrective and Preventive actions (CAPA).
• The QMS specialist will ensure that the EU distributor audit process is in line with company requirements
• You will organize and lead Management reviews at regular intervals during the year to evaluate opportunities to improve
• Raise Employee Quality awareness and satisfaction of the customer
REQUIREMENTS
• You are experienced in ISO13485
• A good and professional working knowledge of distribution business within a medical device environment
• Audit experience
• The ability to communicate on different levels within different environments and be able to translate the requirements back into action or other levels to stakeholders
• You have project management experience and skills
• Have the capacity to communicate and engage stakeholders in supporting QA initiatives for a strong QMS
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.
