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 Utrecht Netherlands.
They are a young and innovative company with an stimulating environment. They take the responsibility to establish innovative solutions and methods for medical issues.
ROLE DESCRIPTION
The company is looking for a new team member to strengthen the current QA team. You will be a key member of the Quality Team and be a single point of contact for distributors and key-stakeholders. You will work directly with other parties both internal as external. The length of the contract is unknown but expected to be at least 9 months to a year with possible extension.
RESPONSIBILITIES
As the new QA officer your main responsibility will be to develop and maintain an effective complaint processing system. Improve this process and ensure effective compliancy with legal and regulatory requirements. Other responsibilities include but are not limited to:
• Maintain and process documentations and file reports concerning complaints and associated cGMP documentation and Medical Device Vigilance Reports (MDR)
• Communicating with other departments addressing and reporting customer complaints
• Conducting investigations ensuring that corrective actions and preventive actions (CAPA) are effectively performed and further actions are fully identified
• Maintain awareness of current and future products, regulations and requirements
REQUIREMENTS
• A degree in preferably Engineering/Science
• Quality and Regulatory experience of at least a year, a highly regulated environment is a big pre
• The desire to give off excellent results, have the attention for details and willing to develop yourself
• Excellent communication skills
• Fluent in English is a must due to the international nature of the company
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.
