Senior Quality Consultant
Location: BelgiumSIRE 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 Brussel Belgium.
They are a Global leader in the Pharma Industry and have branches that are specialized in Medical devices. At the moment they are looking for a Senior Consultant in Quality Assurance.
ROLE DESCRIPTION
As the Quality Consultant you will provide support within the Quality Department by Project management and priority management for the QA department. Your tasks will be focused on key projects and initiatives to develop/standardize the quality systems with the quality strategy.
RESPONSIBILITIES
The Senior Quality consultant will be responsible for implementation of the ISO 13485:2016/IVDR and MDR requirements. Next to that you will responsible for but not limited to:
• Providing Quality Engineering support to assure appropriate actions validation, control and development for new products and failure investigations
• Support business with quality issues and records, non-conformities, CAPA’s, Change control
• Internal Audits and collaborate with stakeholders to ensure business and quality needs are met
• Coaching and trainings of company associates
• Drive change management within the company
REQUIREMENTS
• Project management skills
• Experience in Quality Systems.
• Knowledge of relevant regulations (FDA 21CFR part 820, EMA, ISO 13485, CLIA/CAP)
• Outstanding written and oral communication skills in English
• Knowledge of molecular biological assays
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.
