Quality Assurance Manager Surgical instruments
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 Brabant Flamand Belgium.
This organisation is a Medical Device startup which is present on the market for 3 years now. They have established their name and products now, and are experiencing continuous growth. Their aim is to improve the efficiency in operation rooms, and therefore they develop devices to improve surgery.
ROLE DESCRIPTION
In your role as QA manager, you will also be involved with Regulatory Affairs activities. You will take the lead when it comes down to the improvement and maintenance of the QMS and related activities, including all required documentation and regulations. You will be supported by the RA associate and together you will assure that Quality is guaranteed. You will be the organisation’s contact person when it comes down to Quality and Regulatory issues for both internal and external authorities. This project is set for a period of 6 months with a possibility for extension to 8 months.
RESPONSIBILITIES
As mentioned previously, you are playing a major role in advising the organisation about Quality Assurance and Regulatory Affairs. On a daily basis you are completely involved with the Quality Management System. Further responsibilities include:
• Identifying points of development for the QMS and making adjustments in relevant documentation
• Offering guidance regarding risk assessment and CAPA’s in order to meet the regulatory standards
• Ensuring compliance for product launches and product registrations for existing and new markets
• Establishment and maintenance of relationships with departments and external stakeholders on a global level
• Management and control of QMS documentation and reviewing these documents
• Interaction and communication with both internal and external stakeholders concerning product launch and regulations
REQUIREMENTS
• Bachelor in Life Sciences
• Minimal 6 years of experience within the Medical Devices industry
• Minimal 3 years of experience within a QA role
• Excellent knowledge of ISO 13485: 2016 standards
• Great knowledge of European and international regulation, especially the MDD EEC 93/42
• Fluency in both Dutch and English
• Eye for detail and excellent analytical skills
• Proven experience in improving and developing Quality Management Systems
• Pro-active attitude
• Excellent problem-solving skills
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.