Quality Specialist
Location: NetherlandsSIRE® is the market leader in Life Sciences recruitment. We believe the recruitment market needs to gear up in technology and continuous innovation. We like technology, in a Life Sciences 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!Our client is a professional Medical Devices organisation, based in Gelderland Netherlands.
• The team including you will be responsible for but not limited to ISO 13485 & 9001, Risk Management ISO 14971, if necessary support in Regulatory Affairs
• Be a part of improving the Quality Awareness in the company as well as Change Management
• Support technical files and documentations
• Conducting and support Internal and external audits
• At least 3 to 5 years working experience within a similar position and environment (medical devices/Pharma/Biotechnology)
• Fluent in Dutch and English
The Company
They are a young and ambitious company as a dynamic international distribution department. They are a growing company within the medical device industry that increased their strenght in the market and increasing their opportunities for the company and as well for the employees. Due to this growth they are looking for support in the quality team.Role Description
As the new Quality Assurance officer you will work in a team of four and report to the QA manager. You will support all QA developments, implementations and maintenance of all Quality Management Systems (QMS) that are designed conform the strategy of the Company. The team is social, international and above all motivated to put in the effort needed for the company and in each other.Responsibilities
Your main responsibility as the newest QA officer you will go through a transition/learning period and after finishing that support QA activities.• The team including you will be responsible for but not limited to ISO 13485 & 9001, Risk Management ISO 14971, if necessary support in Regulatory Affairs
• Be a part of improving the Quality Awareness in the company as well as Change Management
• Support technical files and documentations
• Conducting and support Internal and external audits
Requirements
• Knowledge of ISO 13485 & 9001• At least 3 to 5 years working experience within a similar position and environment (medical devices/Pharma/Biotechnology)
• Fluent in Dutch and English
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