Quality Assurance Officer IVD
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 Netherlands.
Our client is a major player when it comes down to the development of In-Vitro Diagnostic systems offered to hospitals, research institutions, and labs. This dynamic company is recognized for their high quality standards and innovative products on a worldwidel level. They are specialized in the development of In-Vitro Diagnostic tests which are performed on automated and POC systems.
ROLE DESCRIPTION
You will work in a growing company which currently has about 70 employees. In your role as Quality Assurance officer you will become part of the QA department. You will have a supportive role in which you assist the Quality Assurance manager. A major task within your daily routine is to overview, control, and maintain the Quality Assurance procedures in line with the regulations of product development and manufacturing within the organisation. You will fulfill the role of an expert in QMS and will assist the QA manager to extend this knowledge among the various stakeholders involved in the product development processes.
RESPONSIBILITIES
* Maintain and improve QMS according ISO 13485 and cGMP
* Assisting in the implementation and application of QA regulations and relevant processes
* Offering technical expertise in QA in order to develop strategies, prevent issues and create solutions
* Reviewing and assessing quality assurance related documentation such as protocols, product specifications and validation tests
* Anticipate in risk analyses and internal or external audits
REQUIREMENTS
* Bachelor degree in Life Sciences
* Minimal three years of experience in QA within the Medical Devices sector
* Excellent knowledge of ISO 13485 and cGMP
* Minimal one year of experience with IVD
* Possession of great analytical and problem solving skills
* Fluency in English and Dutch
* Proactive and critical attitude
* Great eye for detail
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.
