QA/RA 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 an global leader with their Medical Device Products that are produced and distributed through the world. In cooperation with their Headquarters in Asia they are looking for a new QA/RA Manager for in the Netherlands to manage the QA and RA projects across the EMEA region.
ROLE DESCRIPTION
The QA/RA Manager manages and supervises the Quality and Regulatory activities related to all products and processes of the company. You will be responsible for the Quality Management System affecting the company compliance, sale, distribution, design and manufacturing of products in EMEA. As the manager you will provide advice and recommendations and furthermore provide support in the development, auditing and maintenance of the QMS.
RESPONSIBILITIES
• Manage the QA/RA team and their performance including recruitment, evaluations, training, coaching, termination and oversee the QA/RA activities.
• Manage and control all activities related to the maintenance, development and compliance of the Company QMS including Regulatory assessment and requirements.
• Documentation, Product labeling review and approval to ensure compliance with international and local legislation.
• Manage Quality related activities regarding inspections and audits
• Coordinate Post Market Surveillance activities and processes
• Manage sub-contracting contract review, product and clinical testing procedures and protocols and executions from QA/RA perspective.
REQUIREMENTS
• A Bachelor or Master degree
• A minimum experience of 4 to 7 years in QA/RA with high preference of at least 4 years of experience in Medical Devices
• Deep knowledge of Medical Device QA/RA ISO 13485, MDD/MDR
• Knowledge of Practical experience in Technical Process testing, process validation and testing of Medical Devices
• Fluent in English
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.
