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Quality Specialist

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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 organization, based in . They are an international Medical Device manufacturer and currently looking for a new specialist to support them in the Cardiovascular department. They opened up this new role to be responsible for the QMS from the manufacturing plant where the candidate will be closely working with.

Role description

You will coordinate quality measurements and improvement of the Quality Management System of the Medical Plant. This means you will set up and be responsible for the Quality System in the organisation and lead improvement projects to ensure that all quality processes are performed in accordance with the defined requirements. Here you will coordinate, coach and train teams to ensure these requirements and be visible within the plant as the responsible person.

Responsibilities

- Setting up the QMS of the production plant
- Train, coach and coordinate projects to improve quality in the organisation
- Lead Improvement projects
- Perform internal and external audits
- Guidance and documentation of CAPA's
- Support Change Control Projects
- Support Regulatory Affairs team in accordance to quality queries

Requirements

- Minimum of 3 years experience in QA or QS
- Experience in Medical and/or Pharma field
- Knowledge of Quality standards such as ISO 9001, ISO 13485 or FDA 21 CFR 820
- Audit experience is an advantage
- You have a practical above a theoretical approach
- Be able to communicate on different levels



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SIRE Life Sciences

Ref. number: 38115
Listed by: SIRE Life Sciences
Listed on: 02-11-2017
Country: The Netherlands
Employment: Permanent
Expertise: 3 - 5 years
Location Type: On location
Education: Bachelor
Language: English
Sector: Medical Devices
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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