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QA & RA project support
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Jobcode:
8976
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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 couldnt 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.


This organisation is a professional Healthcare and Medical Devices multinational. They are one of the leaders in technological developments and innovation. They are active within a broad range of technology-driven industries, varying from household products to healthcare devices.



ROLE DESCRIPTION


QA and RA are set at a high standard. On a daily basis you are involved with regulated standards, compliancy and you are overviewing developments and required changes within the QMS. In your role as Quality and Regulatory officer, you are responsible for the QMS on the site. You will support to overview, control and improve this system. You are in charge of tracking and being fully aware of all changes within the regulatory domain for Europe and the US. This project is set for 3 months which can be extended to 6 months.


RESPONSIBILITIES


Your daily responsibility contains the overview and maintenance of the QMS for this particular site including the relevant documentation. Furthermore, you are responsible for:

Providing advice and support to management in set up of QA/RA processes

Collecting and creating reports of outcomes from audits especially for CAPAs

Management and control of QMS documentation and reviewing these documents

Taking the lead in organizing internal and external audits, guiding the process from the beginning to the end

Interaction and communication with both internal and external stakeholders concerning product launch and regulations

Creating awareness of importance RA and QA within the corporate organisation by using internal resources

Controlling and assessment of promotion materials with relevant documentation and product specifications


REQUIREMENTS


Bachelor in Life Sciences

Minimal 4 years of experience with QA on a production site within the Medical devices industry

Minimal 2 years of experience in an strictly regulated environment

Proven experience with the maintenance and improvement of QMS

Excellent knowledge of American and European legislation and regulations

Fluency in English, and good understanding of the Dutch language

Critical scope and excellent analytical skills

Understanding and broad knowledge of Lean-six sigma procedures

Team player, yet individual operator




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




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