Quality Assurance Design History File
Location: BelgiumSIRE 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 and Pharmaceutical organization, based in Brussel Belgium.
Is a manufacturer of Medical Devices class 2a. At this very moment they are collaborating with another Medical Devices compay in a joint venture.
ROLE DESCRIPTION
As the Quality consultant you will be responsible for the guidance of the New Product Development, and Quality related items.
You will need to have experience with the ISO13485 subsection " Product Realization" and the 21 CFR Part 820.30 "Design Control"
RESPONSIBILITIES
- Responsible for composing the Design History File
- Responsible for organizing project team meetings to go over Design of Medical Devices
REQUIREMENTS
- Available as from 2nd half of August
- 0,5 FTE project
- Experience with EU and FDA Design Control chapters in the Medical Devices industry
- At least composed 3 DHF files
Are you interested and do want to apply for this role, please fill out your application via the apply button below and contact Tim Thuijs.
