Sr. QMS Specialist EU
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.
Large Medical Devices Company.
ROLE DESCRIPTION
The incumbent is responsible for centralization and governance of the Quality management system across all Europe distribution sites
RESPONSIBILITIES
- Address and evaluate customer satisfaction through the effective operation of the Quality management system, including continual improvement and certification transfer to ISO 13485:2016 standard, while ensuring compliance with Corporate and EU QA procedures
- Manage internal quality audit process, support training of process owners and follows up on improvement actions through the Corrective and Preventive action process
- Ensure robust distributor audit process performed in line with the requirements
- Organize and lead at regular intervals formal Management reviews of the Quality management system
- Increase employee quality and customer satisfaction awareness
- Perform gap analysis and develop plan to achieve successful ISO 13485 certification
REQUIREMENTS
- ISO 13485 experience and exposure
- Good understanding of distribution business in a medical devices environment
- Auditor or lead auditor experience
- Capacity to communicate clearly with various stakeholders and translate complex or dry requirements into processes and actions to be taken by the relevant stakeholders
- Project management skills, capacity to plan and deliver a project within the budget, time and quality committed at the beginning of the project
- Capacity to engage stakeholders in supporting the QA initiatives and act as advocates of a strong Quality Management System
Are you interested and do want to apply for this role, please fill out your application via the apply button below and contact Tim Thuijs.
