A.I. Quality Manager

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 and Pharmaceutical organization, based in Zuid-Holland Netherlands.

This organisation is a market leader that offers services for both the pharmaceutical and medical device sector. They support customers in the development and manufacturing of high technology and innovative products. They are experiencing a continuous growth and therefore, they are looking for the right support.

ROLE DESCRIPTION

In your role as Ad Interim Manager, you will focus on the development and extension of Quality on the site. You will assure that all procedures are compliant and that regulation and legal documentation are completed. On a daily basis you will assess the QMS on the site and in collaboration with your team you will add new capabilities and improvements to the system. In addition, you are the key contact person when there are any questions or particular issues about quality topics for both internal and external stakeholders. Finally, you will make sure that the product specifications are in line with quality standards in order to enable easy market access. This position can be filled in for 8 months with a possibility for extension.

RESPONSIBILITIES

Your priority lies in overviewing and improving the Quality Management System on the site. In collaboration with your team, you will bring new ideas to the quality system. Further responsibilities are:
• You will be on track with the latest developments and changes of QA within the Medical Devices sector
• Development of strategic plans and implementation tools for the improvement of the Quality Management System
• Overview and collect required documentation and legislation in relation to the product specifications
• Review and assessment of procedures involving risk and validation management at the manufacturing site
• Development of strategic plans and implementation tools for the improvement of the Quality Management System
• Tracking and assessing of KPI’s for the quality department

REQUIREMENTS

• Bachelor in Life Sciences
• Minimal 6 years of experience within QA in the Medical Devices
• Excellent knowledge of quality standards such as ISO 13485, 21CFR820, ISO15378.
• Extensive knowledge of EU and US Medical Devices regulations
• Excellent leadership and organisational skills
• Fluency in English and Dutch
• Strong communicator and analytical skills
• Experience with Lean Six Sigma tools and procedures

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.