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Quality Assurance Design History File

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SIRE 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



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SIRE Life Sciences

Ref. number: 27766
Listed by: SIRE Life Sciences
Listed on: 20-07-2017
Country: Belgium
Region: Bruxelles-Capitale
Employment: Freelance
Expertise: 3 - 5 years
Location Type: Home
Language: English
Sector: Pharmaceutical
Specialisation: Quality

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Contact

THE NETHERLANDS

Spiegelhof
Herengracht 466
1017CA Amsterdam
+31 (0) 20 658 9800

BELGIUM

Science 14 Atrium
14b, Rue de la Science
1040 Bruxelles
+32 (0) 2 588 1277

GERMANY

Fünf Höfe
Theatinerstraße 11
80333 München
+49 (0) 89 3803 8966

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