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Software validation & Quality expert

SIRE Life Sciences®

Netherlands, zagranica

SIRE Life Sciences®

Software validation & Quality expert

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

In your role as software QA engineer you will be responsible for the procedures and strategies that are dedicated to provide data within the quality system. You will support the department with validation management involving quality procedures and certain tools that arrive from or need to be implemented in the system. Furthermore, you are involved with internal and external audits where you are the contact person during the process. You will show your expertise by guiding the department in developing software solutions and designs. Finally, you are involved with risk management and change control where you will indicate changes and points of improvement for the QMS. This project is estimated for a period of 1 year with a possibility to extension.

RESPONSIBILITIES

On a daily basis you are involved with the improvement and changes within the system and restructuring processes regarding software solutions. Furthermore, you are involved with:
• Ensuring compliancy of the system regarding European and US quality standards
• Planning and organizing data, plans and collecting reviews of documentation required for the software development lifecycle process
• Providing expertise in the development of Software structures
• Guiding and giving insights into software validation, compliancy and developing recommendations

REQUIREMENTS

• Bachelor in engineering
• Minimal of 7 years of experience with validation of computer system and systems security and control
• Several years of experience within a QA role in the Medical Devices industry
• Experience in working within a strongly regulated environment with standards such as 21 CFR, ISO 13485, GAMP 5
• Excellent knowledge of soft- and hardware, information technology, security and data lifecycle management
• Providing evidence for the ability for validation and software implementation from multiple projects
• Understanding of FDA, notified bodies and other authorities
• Experience in a supervising role
• Excellent communicator and team player
• Strong analytical and organizational skills
• Eye for detail
• Fluent in English and 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.

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SIRE Life Sciences®

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