Quality Control & Assurance associate
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 Groningen Netherlands.
This organisation recently became a medical device subsidiary from an international pharmaceutical market leader. They are specialized in ophthalmology, they produce contact lenses and related products. As their organisation is expanding, there are looking for a qualified team leader.
ROLE DESCRIPTION
As a site lead you are responsible to overview and direct your team for the maintenance and improvement of the QMS. You will become part of an informal and dynamic business setting for which quality is set at a high standard. Furthermore, you will gain insights into improvements and developments for the QA department. You will also lead and organise internal and external audits for which you will make sure that all reports are done correctly. Overall, you will be key to the site, as you are the main contact person whenever there are any issues or questions about the Quality system, ISO standards and required documentation. Furthermore, This project is set for 5 months with a possible extension to 8 months.
RESPONSIBILITIES
You will lead and guide the team at the site. You will overview and collect required documentation and regulations that are compliant to the QMS and ISO standards. Furthermore, your responsibilities involve:
• Identifying and creating tools for the improvement of the Quality Management System
• Approval in product launch and checking on product specifications
• Maintenance of relationships with external and internal stakeholders, involving other departments and notified bodies
• Organisation and execution of internal and external audits among which supplier audits
• Development of training for the site and other involved parties
• Being a support to the engineers at the site
• Controlling and implementing ISO14971 and relevant procedures
REQUIREMENTS
• Bachelor degree in Life Sciences
• Minimal 7 years of experience within the Medical Devices industry
• Minimal 5 years of experience within Quality Assurance and/or Quality Control
• Excellent knowledge of ISO 13485 and ISO 14971
• Broad knowledge of GMP, FDA cfr 820 and CE-marking
• An eye for detail and excellent analytical skills
• Fluency in English and Dutch
• Team player, yet individual operator
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.
