Design Control 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 Noord-Brabant Netherlands.
- You support the team with ongoing changes in the design of the Medical Devices.
- You deploy training programs for the team.
- You give guidance to cross functional teams to establish a compliant QMS and device.
- You provide expertise to quality system related issues.
- Strong knowledge of FDA and European Medical Regulations
- Experience in design of QMS and design of devices
- Hands on attitude
- Availability for longer period of time (1 year 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.
The Company
They are an international manufacturer and distributor of Medical Devices and Healthcare devices. The organisation provides an innovative and high tech working environment with room to grow and develop for their employees. At the moment they are looking for a new QA specialist specifically experience with FDA and Design control.Role Description
You will work in an international team within the company that focusses on document control aspect of FDA. You will guide the project team through the Quality requirements of designing a variety of medical devices. These medical devices will be hardware and software devices. You will operating in between R&D, Quality Assurance and Regulatory fieldResponsibilities
- Your main task is to provide oversight to the QMS process development, implementation and make sure deadlines are hit.- You support the team with ongoing changes in the design of the Medical Devices.
- You deploy training programs for the team.
- You give guidance to cross functional teams to establish a compliant QMS and device.
- You provide expertise to quality system related issues.
Requirements
- 3 years of experience in Medical Devices QA- Strong knowledge of FDA and European Medical Regulations
- Experience in design of QMS and design of devices
- Hands on attitude
- Availability for longer period of time (1 year 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.
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