Quality Assurance Manager
SIRE Life Sciences®
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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 Limburg Belgium.
The CompanyThey have multiples sites in Belgium/Europe and offering medical services over the world. The site close to Brussels is now searching for a QA Manager to support the software Headquarters. They have an informal but passionate environment where every employee is dedicated to their goal to improve the lives of people and prevent critical medical issues. You will be part of an enthusiastic team that is proud of what they are achieving and committed to the job they are performing together.
Role DescriptionThe Quality Assurance Manager will play a key role with our new product introduction team that are taken from concept, design, development to commercialisation. The products from the local site consists is focused on software. The QA Manager in Belgium will ensure compliance with industry guidelines, regulatory standards and company requirements. Responsibilities will also include interfacing with team members from teams such as Marketing, R&D, Manufacturing, Support and Clinical as well as outside organisations such as suppliers, test facilities and regulatory bodies.
Responsibilities1. Develops, implements and maintains Quality Management system and activities within FDA QSR 820, ISO 13485, ISO 27001 and international regulatory guidelines.
2. Serves as site management representative with responsibility for reporting on the performance of the quality system and any need for improvement to top management.
3. Serve as the quality representative for new product introduction and new product improvement projects for all product types; participate in team meetings and coordinate quality activities as required. Focus will be on the clinical bioinformatics software products like Alissa Interpret and Align and Call.
4. Assist in development and execution of regulatory plans for complex projects. Assist in documentation for regulatory meetings with FDA.
5. Monitor applicable regulatory requirements; assure compliance with internal procedures and external standards.
6. Assist with the verification and validation experimental design; coordinate with regulatory affairs and R&D to confirm experimental design conforms to appropriate regulatory requirements.
Requirements1. Bachelors or Master's Degree
2. Solid understanding of medical device design control and regulations as well as Medical Device quality management standards ISO 13485, FDA 21 CFR part 820, EU Medical regulations, ISO 14971, IEC 60601, 62304, 62366.
3. Experience with Medical Software and Electro Mechanical standards is a big pre (IEC 60601 & IEC 62304)
Are you interested and do want to apply for this role, please fill out your application via the apply button below and contact Jeroen Evertsen.