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QA Specialist Medical Devices

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The company

Our client is a professional Medical Devices and Chemicals organisation, based in Utrecht Netherlands. Our client is an international, innovative organisation that is represented in various industries. This particular location is specialized in Medical Devices.

Role description

You will become part of an informal and dynamic business setting in which quality is set at a high standard. You will receive various responsibilities that are directed to maintain and improve the Quality Management System. In addition, you are responsible for the ISO 13485 standards and required documentation. You will be the key person to contact whenever there are any issues or questions about the Quality system, ISO standards and required documentation. Furthermore, you will gain insights into improvements and developments for the QA department.

Responsibilities

On a daily basis you are involved with overviewing and maintenance of the Quality Management System. In addition, on a daily basis you are involved with:
• Development of strategic plans and implementation tools for the improvement of the Quality Management System
• Gain insight into possible points of improvements for the QMS according to ISO 13485 standards
• Providing support to management in set up of QA/RA processes
• Collecting and creating reports of outcomes from audits especially for CAPA’s
• Management and control of QMS documentation and reviewing these documents
• You will be on track with the latest developments and changes of QA within the Medical Devices sector, involving regulations & legislation such as the MDR and FDA

Requirements

• Bachelor in Life Sciences, preferably in chemistry
• Minimal 4 years of experience with QA on a production site within the Medical devices or Pharmaceutical industry
• Proven experience with the maintenance and improvement of QMS
• Experience with audits and inspections of notified bodies and other authorities
• Excellent knowledge of American and European legislation and regulations
• Fluent Dutch language and business proficiency English
• Critical scope and excellent analytical skills
• Team player, yet individual operator

Other information

Heb je interesse en wil je meer weten over deze functie, reageer dan door op solliciteer te klikken en contact op te nemen met Juliette van Kraaij


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SIRE Life Sciences®

Ref. number: 43171
Listed by: SIRE Life Sciences®
Listed on: 15-05-2019
Country: The Netherlands
Region: Utrecht
Employment: Permanent
Expertise: 3 - 5 years
Location Type: On location
Education: Bachelor
Language: Dutch
Sector: Medical Devices
Specialisation: Quality

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Contact

SIRE Life Sciences B.V.

Mondriaan Tower
Amstelplein 52, 25th floor
1096 BC Amsterdam
+31 (0) 20 658 9800

SIRE Life Sciences Belgium BVBA

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

SIRE Life Sciences Deutschland GmbH

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

SIRE Life Sciences Maastricht

ROOOMS Maastricht
Boschstraat 21
6211 AS Maastricht


SIRE Staffing Solutions

Keizersgracht 420 C
1016 GC Amsterdam
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SIRE Chemicals

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Stationsplein 45 4th Floor
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+31 (0) 85 044 4610

SIRE Healthcare

Mondriaan Tower
Amstelplein 52, 25th floor
1096 BC Amsterdam
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SIRE Human Resources

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SIRE Staffing

Mondriaan Tower
Amstelplein 52, 25th floor
1096 BC Amsterdam
+31 (0) 85 044 4650

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