QMS specialist for the European market

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-Holland Netherlands.

A global market leader which aims to improve healthcare. They offer a broad range of products and are continuously growing. They are expanding in various industries, where they offer products varying from neurotechnology to surgical instruments. They are an innovative and technology-driven organisation that focuses on improving lives.

ROLE DESCRIPTION

As mentioned you will become part of a dynamic and technology- driven business setting. On a daily basis you will interact with clients to check on the maintenance and efficiency of the QMS. Your aim is to improve the quality system in which you are supported by internal and external stakeholders. In particular, you will identify points of improvement that are related to ISO 13485:2016 standard, and which are in line with Corporate and European Quality Assurance procedures. You are the point of contact when it comes down to questions over or discrepancies within QMS. This project lasts for 5 months, with a possibility for extension.

RESPONSIBILITIES

As a quality system specialist, you are responsible for the Quality Management System in general. You will receive the responsibility to maintain, asses and improve the QMS, and keep on track of relevant changes and specifications applicable to the system. Furthermore, your role includes:
• To be aware of the internal and external regulations including ISO qualifications.
• To overview 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.
• Maintenance of relationships with both internal and external stakeholder
• Keeping on track with the KPI’s of the quality department
• Development and execution of training directed across departments
• Execution of Gap analyses

REQUIREMENTS

• Bachelor of Science
• Minimal 3 years of experience in the Medical Devices industry
• Minimal 2 years of experience in Quality Assurance within the Life Sciences industry
• Excellent analytical and problem-solving skills
• Fluency in English and Dutch
• 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

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.