A.I. Quality manager women healthcare
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-Brabant Netherlands.
This client is specialised in the development and improvement of pregnancy monitoring. This organisation is high technology driven and focuses on innovation. This organisation was established by combining science, technology and medicines within one company.
ROLE DESCRIPTION
As a quality manager you are responsible for the compliancy of the products and to ensure that the organisation meets the customer demands. You are constantly involved with various departments within the company. You will participate in the development and improvement of the products and see how these are in line with the quality standards and required regulations. On a daily basis you are involved with the quality management system and regulatory issues. You will be the contact person when it comes down to regulatory and quality issues both with internal and external stakeholders. The duration of this project is estimated for 6 months and has the possibility to be extended.
RESPONSIBILITIES
On a daily basis you are fully involved with both regulatory and quality topics. Your aim is to improve the QMS and control all required legal documentation. Further responsibilities involve:
• Guidance and support concerning quality and regulatory issues across departments
• Overviewing and keeping on track with quality developments and changes within documentation and legislation on a European and international level
• Supporting audits from the beginning to the end
• Key contact person for internal and external stakeholders, involving authorities and auditors
REQUIREMENTS
• Bachelor in Life Sciences
• Minimal 4 years of experience within a Quality and Regulatory role in the Medical Devices industry
• Excellent knowledge of quality standards ISO 9001 and ISO 13485
• Eye for detail and strong analytical skills
• Team player, yet strong decision maker
• Fluency in Dutch and English
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.
