Quality Assurance Manager
Location: NetherlandsSIRE 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 Noord-Holland Netherlands.
They are a world leading manufacturer that is committed to solve difficult needs through an innovative research and development process. It offers great development and career opportunities for devoted specialists across the globe.
ROLE DESCRIPTION
As the Quality Assurance Manager you will take on the task to provide leadership to the company and the Quality expectations, ensuring compliancy to regulatory requirements and meets customer needs.
RESPONSIBILITIES
Your responsibilities is to define the strategy for the company, where the priorities lay and implement these improvements through routine maintenance. You will where needed coach and train employees of your team. Other responsibilities would be:
• Maintain the Quality Systems concerning ISO 9001, ISO 13485 and 21 CRF820
• Support the development of new products regarding regional launch processes, quality issue resolutions and local regulatory requirements.
• Meeting the annual objectives of your, and your teams’ tasks
• Cooperate with Regulatory Affairs team to implement country specific requirements
• Interact with the Supplier Management on a global level for local suppliers
REQUIREMENTS
• Bachelors Science Degree
• A minimum of 3 -5 years Quality Assurance experience preferably within a management or lead role in a highly regulated environment
• Proven and well developed knowledge of ISO 9001, ISO 13485, 21 CFR820, GDP and EU MDD
• Experience on an international environment
• Supervisory skills and able to communicate effective and efficiently across different levels of the company
• At least a basic understanding of Six Sigma and Lean systems
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.