QA specialist distribution site
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 Netherlands.
This client is operating on an international level within various industries. As for their healthcare business unit they are market leader in offering logistic solutions and strategic plans for the distribution of healthcare and medical device products. As this organisation is continuously developing and expanding, they decided to establish a distribution center in order to cope with this growth.
ROLE DESCRIPTION
In your role as Quality Assurance Manager, you are located at the distribution site, for which it is crucial to establish and maintain relationships with key stakeholders of the organisation. In collaboration with the site director you will develop your strategy and vision for the site. You will take the lead of the Quality team in which you create awareness and share your knowledge about the value of Quality Assurance. This position crosses the standard control of QMS and collecting documentation, you will be an expert on QA in which you are the company’s representative for notified bodies and authorities. You will receive the opportunity to create tools to improve and maintain the company’s high quality standards. This role can be filled in for at least 3 months
RESPONSIBILITIES
As mentioned previously your priority lies in the assurance of Quality at the distribution site. The next major task is to be the QA expert for both internal and external stakeholders. Additionally, this involves:
• Development of quality improvement processes and creation analytic tools.
• Preparation and supervision of internal and external audits
• Apply and improve Quality Management System
• Maintain and apply QA standards and compliance in relation to global and European regulations
• Identification of discrepancies in CAPA and offering solutions
• Creation of objectives and strategies validating Quality Assurance
REQUIREMENTS
• Master degree in Life Sciences
• 6 years of experience within Quality Assurance and Regulatory Affairs within the Medical Devices sector
• 3 years of experience within a management role in Medical Devices company
• Knowledge of ISO 13485 into detail
• Experience with Risk and change management
• Fluency in English and Dutch
• Experience with QMS and MMD principles
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.
