Quality Assurance Officer
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.
They are a young and dynamic company and develop and produce Medical Diagnostic Devices for multiple international Companies in the world. They are looking for a new QA officer to support the team and divide the increasing work load.
ROLE DESCRIPTION
You will work within the QA department under supervision of the QA Manager and will focus specifically on giving support on all QA related tasks and manage/supervise the compliancy of the Quality Management Systems regarding all current regulations that are relevant to the Company products (ISO 13485, 21CFR820).
RESPONSIBILITIES
As the new officer of Quality Assurance your day to day tasks will focus on safeguarding the compliance of all production processes and manufacturing within the company. Focusing on ISO 134854 and the 21 CFR 820 (cGMP) your responsibilities and tasks would be:
• Supporting and ensuring improvement of Quality mentality and awareness within the company
• Ensuring that all processes and internal procedures are conform the Medical Device regulations and will be conform future regulations
• Supporting product development, assessment and strategies for corrective and preventive actions (CAPA’s)
• Participate in audits and risk assessments
• When needed you will take a part of the responsibility of Complaint handling (PMS)
REQUIREMENTS
• At least a bachelor degree with a medical or biological background
• A minimum of three years experience in QA within a highly regulated environment
• Knowledge and understanding of ISO 13485 and 21 CFR 820
• Fluent in both English and Dutch
• Experience within IVD is a big plus
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.
