QA Manager
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 world player in the industry of Medical Devices focused on ear devices and healthcare. They are looking for a new QA manager to extend the current team in Belgium.
ROLE DESCRIPTION
The new Manager Quality Assurance will take on the task of maintaining and improving the Quality Management Systems and make them compliant with the MDD/MDR. He/she will focus on the newest products and will make sure that all quality related affairs are conform the Directives, ISO 13485 and FDA. You will take the lead over the team of Quality officers and ensure compliancy from all aspects of Quality with your team. You will take lead in projects and guide these projects and registrations to achieve successful certifications of their products.
RESPONSIBILITIES
• Responsible for the Quality Management systems
• You will be representative as a part of management and responsible for the Quality Team working under you
• Where needed you will train and coach Quality Officers
• Support and cooperate with the Regulatory Affairs team
• Implement Corrective and Preventive Actions (CAPA's) and ensure product safety and efficiency
• End responsible of Post Market Surveillance of Benelux region
REQUIREMENTS
• Quality Management Background and degree
• At least 5 years of related working experience
• At least 2 year of management and Supervising experience
• Deep knowledge and understanding of ISO 13485, FDA 21 CFR 820
• Fluent in English written and speaking
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.
