Manager Quality Assurance
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 Limburg Netherlands.
They are a leader in Europe that supports customers in Medical Device queries, inspections, processes and regulations compliancy. Due to fast growth the company needs a new Quality Assurance Manager that can take over tasks specifically for Quality Assurance related issues.
ROLE DESCRIPTION
Your tasks will be focussed on QA and the compliancy herein. You will maintain and improve the Quality Management System of the company and ensuring the compliancy regarding ISO 13485 and preparing it for the new ISO 13485:2016. You will lead audits both internal- and externally, you will manage and review CAPA’s and conduct risk management.
RESPONSIBILITIES
Your main responsibilities will be to manage the onsite QMS and focused priorities to compliancy with the regulatory requirements. Other responsibilities would be:
• Conduct internal and external audits and report findings
• Conduct risk assessment, find possible improvements and make sure these are implemented
• Prepare new ISO 13485:2016 and ensure that company is compliant by the given deadline
• Make recommendations and corrective actions regarding the generated QA report made by you
• Process and document non-conformities
• Serve as contact person for all Quality related issues in EMEA the company as well as being responsible for complaint handling
REQUIREMENTS
• A degree in science, preferably Master
• At least 5 years of experience in the Medical device industry and at least 3 year within a QA position
• Knowledge and understanding of ISO 13485, CAPA’s, non-conformities and complaint handling
• Being an independent worker that does not need training in QA Medical Devices environment
• Professional level of fluency in English and Dutch
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.
