Quality Engineer

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 organisation might not be the first Medical Device organisation you would have in mind, as they are generally an international pharmaceutical giant. They are operating worldwide and there ultimate goal is to improve international healthcare.

ROLE DESCRIPTION

In your role as quality engineer you are involved with change control, risk management, validation management and CAPA management. You will be part of an international business setting where you will be involved with EMEA and US regulations. You are a key stakeholder when it comes down to the management and coordination of national and international standards and documentation for the Medical Device sector. Furthermore, you will assist in the improvement, maintenance and the creation of efficiency for the Quality Management System. On a daily basis you will be dealing with software and the combined health products. You will be coordinating and overviewing the regulations and developments within the Medical Devices industry across the European and international market. This project is set for one year with a possibility for extension.

RESPONSIBILITIES

As mentioned previously you are mainly involved with the maintenance and improvement of the Quality Management System. Further responsibilities involve:
• Supporting and guiding audits from the beginning to the end
• Acting up on notifications retrieved from audits such as CAPA’s and risk management procedures
• Implementation, monitoring and maintenance of FDA Quality standards, ISO and Medical Device Regulations
• Creating internal awareness for particular quality issues and developments
• Involvement and participation in development of business plans in which a regulatory point of view is required
• Taking the lead in creating an international regulations strategy involving CE-marking, product specifications and related legislation, and particular
evaluations
• Establishment and maintenance of relationships with departments and external stakeholders on a global level

REQUIREMENTS

• Bachelor in Engineering
• Minimal 6 years of experience in the Medical Device industry
• Minimal 4 years in a Quality role
• Experience with improvement and implementation of Quality Management Systems
• Excellent knowledge of ISO 13485 and required regulation among which the MDR and the FDA, in particular the 21 CFR 820,
• Excellent knowledge of risk management
• Experience with the establishment of relationships with internal and external stakeholders
• Strong communicator and team player
• Strong analytical and organizational skills
• Fluent in English, Proficiency in Dutch

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.