Quality Management System specialist

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 organization, based in Noord-Brabant Netherlands.

This international market leader within the Medical Devices industry is continuously growing. They are one of the leaders in technological developments and innovation. They are active within a broad range of industries, and focus on technology and innovation.

ROLE DESCRIPTION

As a QMS manager your main responsibility is to improve the quality system in which you are supported by your team, other departments and external stakeholders. In relation to this responsibility, you focus on the maintenance and coherence between the system and the required regulations and policies of the organisation. You will give guidance to a team of specialists and you look for identification of improvements. As a Quality Management System specialist you will make sure that all processes are compliant and you are the point of contact when it comes down to questions about or discrepancies within QMS. Furthermore, you create and provide trainings for your team and other departments to create understanding and exchange information of Quality Assurance and procedures. This project lasts 7 months with possible extension to a year.

RESPONSIBILITIES

You will become part of a very dedicated and ambitious environment. Your team contains diverse disciplines that differ from software specialists to post market surveillance experts. Furthermore, your responsibilities include:
• Taking the lead in overviewing processes and applications conducted by your team which includes Audits, CAPA, Document control, risk- and
supplier management.
• Constantly analyzing the data and processes to trace risks and identify improvements.
• Execution, organizing and creating report from GAP analyses
• Development and providing of training directed across departments and external parties
• Monitoring the Key Performance Indicators from the Quality department, including creating strategies and tools for improvement
• Creating and maintaining awareness of the internal and external regulations including ISO qualifications, in particular ISO13485
• Key contact person for the maintenance and establishment of relationships with internal and external stakeholders

REQUIREMENTS

• Bachelor in Life Sciences
• Minimal 7 years of experience in the Medical Devices industry in a Quality Assurance role
• Excellent knowledge of ISO 13485 standard and 21CFR820 regulation
• Strong in communication and establishment of relationships with various stakeholders
• Proven experience in relationship building and maintenance of relations with authorities and other external stakeholders
• Lead auditor certification
• Experience with software and information technology business applications
• Fluency in English, and understanding of Dutch language
• Excellent analytical and problem-solving skills
• Evidence of leadership ability and organizational skills

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.