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QA Software Specialist

SIRE Life Sciences®

Belgium, zagranica

SIRE Life Sciences®

QA Software Specialist

Location: Belgium
SIRE® is the market leader in Life Sciences recruitment. We believe the recruitment market needs to gear up in technology and continuous innovation. We like technology, in a Life Sciences 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!Our client is a professional Medical Devices organisation, based in Vlaams-Brabant Belgium.

The Company

Our client is a professional Medical Devices organization, based in Brabant Flamand Belgium. As one of the world’s largest provider of dental solutions, varying from implants, prosthetics, imaging systems and more, our client keeps innovating and advancing towards more effective and efficient care for its customers. With their global headquarters in the United States, they have a location in Belgium as well to meet the needs of the Benelux market.

Role Description

As the quality assurance R&D specialist, you will be responsible for making contributions to the international quality management system. Your field of expertise will be the medical devices software and you will be the deputy QA Manager for the software products.

Responsibilities

• You will establish and improve the quality processes to make sure the software is complaint to the currently applicable regulations and standards
• You will perform internal auditing and quality reviews for the software development, as well as participate in the external audits
• You will provide trainings to the colleagues regarding the quality processes
• Regulatory Affairs will be supported by the quality assurance specialist
• You will define strategies and plans for further improvement of software validation and quality
• Participate in international QA/RA projects and product registrations

Requirements

• You have at least 5 years of experience in quality assurance of medical devices software
• You must be a certified internal auditor, preferably experience with supplier auditing
• Good knowledge of the following standards and regulations: ISO13485, ISO62304, IEC62366, ISO14971, 21CFR820
• You are proficient in English
• You have a background in design controls and root cause analysis
• You are willing to travel from time to time

Are you interested and do want to apply for this role, please fill out your application via the apply button below and contact Nicolas Gyselinck.
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SIRE Life Sciences®

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